MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-06-07 for ACCESS? HLH REAGENT 33510 manufactured by Beckman Coulter, Inc..
[2007285]
The customer contacted beckman coulter, inc (bci) to report erroneous "no value" results for luteinizing hormone (lh) for four patient samples assayed using the access hlh reagent on an access 2 immunoassay system. The patient results were not reported out of the laboratory. There was no reported patient impact. The customer reported that quality controls were assayed earlier in the day prior to assaying the patient samples. All quality control results were within their respective ranges. The customer subsequently inserted a freshly opened hlh reagent pack onto the access 2 immunoassay system and re-assayed the four patient samples. Numerical results were obtained for each of the patient samples and all quality control results were within their respective ranges. A definitive root cause for this event has not yet been determined.
Patient Sequence No: 1, Text Type: D, B5
[9128565]
Method: evaluation and troubleshooting activities were conducted via telephone. Result: erroneous data generated. Conclusion: a definitive root cause for the event has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-01649 |
| MDR Report Key | 2115518 |
| Report Source | 06 |
| Date Received | 2011-06-07 |
| Date of Report | 2011-05-11 |
| Date of Event | 2011-05-11 |
| Date Mfgr Received | 2011-05-11 |
| Date Added to Maude | 2011-09-19 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| 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? HLH REAGENT |
| Generic Name | HUMAN LUTEINIZING HORMONE ASSAY |
| Product Code | CEP |
| Date Received | 2011-06-07 |
| Catalog Number | 33510 |
| Lot Number | 021773 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-07 |