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.
[3187813]
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 patient's samples, on the same analyzer, recovered similar elevated results. Additional analysis of the patient's 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 patient's 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 patient's samples for further analysis. This is report thirteen of sixteen, referencing patient #13.
Patient Sequence No: 1, Text Type: D, B5
[10570254]
Service was not dispatched as the customer did not question system performance. During the ivf procedure, the physician administered the following medications: gonadotropin releasing hormone (gnrh) analogues: lucrin, decapeptyl. Gnrh antagonists: orgalutran, cetrotide. Rec. Fsh: gonal f, puregon. Urinary: menogon, merional, menopur, metrodin hp. A review of the customer-supplied quality control (qc) data from (b)(4) 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)(4) 2013, was within expectations. Assay calibration, from 01/09/2013, 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
[10865222]
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 (b)(4) time frame. Both units produced reproducible qc results over four reagent pack lots, total data points of (b)(4). There is no overall imprecision claim for this assay, however, this data is within the imprecision as defined by (b)(4). (b)(4). 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 (b)(4) 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
[20407093]
Additional information: 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
| Report Number | 2122870-2013-00146 |
| MDR Report Key | 2968872 |
| Report Source | 01,05,06 |
| Date Received | 2013-02-19 |
| Date of Report | 2013-01-24 |
| Date of Event | 2012-04-04 |
| 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 |