MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-02-19 for ACCESS? PROGESTERONE 33550 manufactured by Beckman Coulter.
[3187812]
The affiliate reported the customer alleged elevated progesterone results, for sixteen patients, on separate days, involving the unicel dxi 800 access immunoassay system used in conjunction with access progesterone assay. The customer stated the unexpected shift in progesterone values (above the laboratory's protocols of 1 ng/ml) were not observed in the past. Subsequent analyses of the patients' samples, on the same analyzer, recovered similar elevated results. Additional analysis of the patients' samples, through an alternate methodology, recovered lower progesterone results within the customer's expectation. The elevated results were released out of the laboratory. As a result, the patients' ivf (in vitro fertilization) embryo transfer cycles were cancelled. There has been no report of additional patient treatment or current patient outcome to date. The customer will supply beckman coulter with several patients' samples for further analysis. This is report eight of sixteen, referencing patient #8.
Patient Sequence No: 1, Text Type: D, B5
[10569844]
Service was not dispatched as the customer did not question system performance. During the ivf procedure, the physician administered the following medications: gonadothropin releasing hormone (gnrh) analogues: lucrin, decapeptyl. Gnrh antagonists: orgalutron, centrotide; rec. Fsh: gonal f, puregon; urinary: menogon, merional, menopur, metrodin hp. A review of the customer-supplied quality control (qc) data from (b)(6) 2013 through (b)(6) 2013 indicates the percent coefficient of variation (cv) for the low control is 19%, which is higher than the minimal essential cv of 18% at 1. 1 pg/ml as stated in the access immunoassay post-market release performance data. The laboratory's expectation is 21% cv at 0. 81 pg/ml. Level 2 qc percent coefficient of variation was at 6. 5%, which appears to be within the cv requirements. System check, from (b)(6) 2013, was within expectations. Assay calibration, from (b)(6) 2013, passed within specifications. At present, beckman coulter continues to investigate this reported event. All related medwatch reports associated with this event: 2122870-2013-00134, 2122870-2013-00135, 2122870-2013-00136, 2122870-2013-00137, 2122870-2013-00138, 2122870-2013-00139, 2122870-2013-00140, 2122870-2013-00141, 2122870-2013-00142, 2122870-2013-00143, 2122870-2013-00144, 2122870-2013-00145, 2122870-2013-00146, 2122870-2013-00147, 2122870-2013-00148, 2122870-2013-00149.
Patient Sequence No: 1, Text Type: N, H10
[10825346]
Beckman coulter received two patient samples from the customer for investigation. The samples were sent to an external laboratory for testing on an alternate methodology. Testing confirmed the progesterone results, on the alternate methodology, were lower than the customer's progesterone values originally obtained on the unicel dxi 800 access immunoassay system. There was inadequate patient sample to repeat the testing on the unicel dxi 800 system or perform any additional investigation. Results with an alternative methodology (cobas-roche): sample 1: 0. 685 ng/ml (<1. 0 ng/ml); sample 2: 1. 37 ng/ml (<1. 5 ng/ml).
Patient Sequence No: 1, Text Type: N, H10
[15330994]
Additional information: beckman coulter further reviewed low level quality control (qc) between the involved unicel? Dxi 800 system and another unicel? Dxi 800 instrument over an approximately 2-month time frame. Both units produced reproducible qc results over four reagent pack lots, total data points of 75. There is no overall imprecision claim for this assay, however, this data is within the imprecision as defined by the benchmark of a standard deviation of less than 0. 35 ng/ml at concentrations of less than 3. 5 ng/ml. Reference: access? Immunoassay post-market release performance data. Response is accurate as judged vs. The january 2013 unity data, as all means by reagent pack lot and instrument are within 1 sdi of the unity dxi data. Sample ids cited in the longitudinal patient studies, those analyzed the first week of january 2013, are analyzed and indicates the patient data is consistent between both instruments and between differing reagent pack lots in use. Following the access? Current united states pharmacopeia (usp) calibration, the two samples returned and tested, using the roche methodology, were within the customer in vitro fertilization (ivf) protocol literature expectation. The roche methodology is calibrated to gas chromatography mass spectrometry (gc-ms). Given the roche result observation, recent proficiency testing data, across two methodologies, roche and abbott was reviewed. Proficiency testing review of cap, neqas and api, at low concentrations, indicate a high bias for the access? Methodology vs. The roche and abbott methodologies. The roche calibration traceability is to gc-ms, at least since 2005. The abbott calibration traceability is unclear as the instructions for use (ifu) states, matched to an abbott internal reference standard. Given the proficiency testing observations of the abbott and roche responding lower vs. Access? , the longitudinal patient data was inspected for effective pairing of access? Sample and abbott results from the same patient, on the same day. Seven samples, from 2013-01-03, were observed, fitting these criteria. The observed access? Usp calibration responses were converted to the gc-ms access? P4de calibration using the final correlation data (b)(4), using only the regression obtained from access? Usp response concentrations up to 3. 0 ng/ml. This relationship was determined as: access? P4de = 0. 7171 access? Usp = 0. 0689. Converting the access? Usp calibrated response to the p4de response brought the average difference between the access? Methodology to the abbott methodology from a significant mean difference of plus 0. 46 ng/ml (p-value 0. 0066) to an insignificant mean difference of 0. 01 ng/ml (p-value 0. 8892). In conclusion to the investigation, the customer interpreted the progesterone assay performance against literature references in the ivf protocols. The literature references are citing the progesterone response as calibrated vs. The current international federation of clinical chemistry (ifcc) recognized of id/ gc-ms reference methodology for calibration of the assay. Based on this investigation, the customer could best be served by conversion to the access? P4de calibration. The progesterone assay associated is functioning as intended. Results of the investigation indicate that the incident is associated with the progesterone assay in lieu of the unicel? Dxi 800 access? Immunoassay system. The customer has not reported any additional incidents or similar incidents over the past year.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2013-00141 |
| MDR Report Key | 2968850 |
| Report Source | 01,05,06 |
| Date Received | 2013-02-19 |
| Date of Report | 2013-01-24 |
| Date of Event | 2012-12-27 |
| Date Mfgr Received | 2013-02-20 |
| Device Manufacturer Date | 2012-07-01 |
| Date Added to Maude | 2013-02-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS? PROGESTERONE |
| Generic Name | RADIOIMMUNOASSAY, PROGESTERONE |
| Product Code | JLS |
| Date Received | 2013-02-19 |
| Model Number | NA |
| Catalog Number | 33550 |
| Lot Number | 222209 |
| ID Number | SOFTWARE VERSION V4.4 |
| Device Expiration Date | 2013-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-02-19 |