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 2014-10-06 for ACCESS HLH 33510 manufactured by Beckman Coulter.
[22262822]
The customer reported repeatable false positive luteinizing hormone (hlh) results for seven (7) patients with precocious puberty signs, generated from their laboratory's two unicel dxi 800 access immunoassay systems, during (b)(6) 2013 to (b)(6) 2014. Serial numbers for the instruments are (b)(4). The sample from patient 7 was tested on the dxi 800 instrument with serial number (b)(4). It is unknown which of the two dxi 800 instruments some of the results were generated from. The customer reported that high hlh results did not decrease as expected, after the patients were provided treatment with a lh/rh analog. The laboratory expected hlh results to be well under 1 miu/ml after treatment. Because the hlh values generated by the dxi 800 analyzers did not decrease after treatment, the customer alleged that some patients received unnecessary injections of lh/rh analog. The customer also stated that the dxi analyzers sometimes generated high hlh results for young patients without signs of puberty. Re-analysis of some of these samples on an alternative method generated expected low hlh results (<1 miu/ml). The customer also inquired if drugs such as lucrin leuprolide acetate and decapeptyl triptorelin acetate administered to patients may be a source of interference with the assay. The luteinizing hormone (hlh) reagent was used in conjunction with the unicel dxi 800 access immunoassay system for this event. This report is 1 of 17 related reports and represents the hlh result for patient 4 generated on a dxi 800 instrument on (b)(4) 2014.
Patient Sequence No: 1, Text Type: D, B5
[22342376]
(b)(6). The full patient identifier is (b)(4). The customer provided archive data files for both dxi instruments and analysis of the files did not reveal an issue with the instrument and/or assay performances. The customer provided quality control (qc) results for both analyzers which indicate that qc is recovering within the customer's established ranges. Calibration curves for the hlh assay run on both analyzers also passed with good specifications that are within the assay's guideline. Analysis of event logs from both instruments also did not highlight any specific issue except a high occurrence of sample handling related errors, namely "insufficient sample in sample tube" and "aspiration monitor detected possible obstruction" errors. The customer provided beckman coulter with two (2) patient samples for investigation. Beckman coulter tested the patient samples neat (undiluted and unaltered) following centrifugation for the hlh assay and obtained high hlh results which confirmed the customer's results. Beckman coulter then performed an interference testing using a mix of different blockers which demonstrated the presence of an interference substance related to alkaline-phosphatase, causing generation of falsely elevated hlh results. In conclusion, the cause of the falsely elevated hlh results may be attributed to the presence of an interfering substance related to alkaline-phosphatase. This report is one of seventeen reports associated with this event. The following is a list of all reports associated with this event: 2122870-2014-00673, 2122870-2014-00674, 2122870-2014-00675, 2122870-2014-00681, 2122870-2014-00682, 2122870-2014-00683, 2122870-2014-00684, 2122870-2014-00685, 2122870-2014-00686, 2122870-2014-00687, 2122870-2014-00688, 2122870-2014-00689, 2122870-2014-00690, 2122870-2014-00691, 2122870-2014-00692, 2122870-2014-00693, 2122870-2014-00694.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2014-00690 |
| MDR Report Key | 4146082 |
| Report Source | 01,05,06 |
| Date Received | 2014-10-06 |
| Date of Report | 2014-09-09 |
| Date of Event | 2014-08-05 |
| Date Mfgr Received | 2014-09-09 |
| Device Manufacturer Date | 2014-01-01 |
| Date Added to Maude | 2014-10-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 BOULEVARD |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS HLH |
| Generic Name | RADIOIMMUNOASSAY, LUTEINIZING HORMONE |
| Product Code | CEP |
| Date Received | 2014-10-06 |
| Model Number | NA |
| Catalog Number | 33510 |
| Lot Number | 470017 |
| Device Expiration Date | 2015-12-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2014-10-06 |