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 2015-06-05 for VIDAS LH 30406 manufactured by Biom?rieux Sa.
[22904178]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[22904179]
On (b)(6) 2015 a customer in (b)(6) contacted biomerieux to report out of range values for the vidas lh test (ref. 30406 lot 1002870450) obtained with the (b)(6) cnqs (national quality control) ia72 and ia73. The cnq was issued to the customer in september 2014 and the results were analyzed by (b)(6) in january 2015. The reason for delay in reporting to the manufacturer is unknown. The lot number used by the customer has expired. No further analyses can be performed for this lot. The ranges defined by the competent authority (b)(6) for this test are: ia72 ranges: 14% (2. 28-3. 02) miu\ml. The customer obtained: 3. 1 mui/ml. Peer-to-peer average: 2. 65 mui/ml. Ia73 ranges: 12% (19. 38-24. 66) miu\ml. The customer obtained: 24. 7 mui/ml. Peer-to-peer average: 24. 7 mui/ml. The customer did not perform other qc samples for this test. Vidas lh is an automated quantitative test for use on the vidas family instruments for the determination of human luteinizing hormone in human serum or plasma (lithium heparin), using the elfa technique (enzyme linked fluorescent assay). There was no death, serious injury or adverse event reported as a result of the discrepant result.
Patient Sequence No: 1, Text Type: D, B5
[34098198]
Internal investigation, though limited due to expiration of the referenced product lot, was performed by biom? Rieux. Evaluation of complaint records indicate no other complaints for the referenced lot for the same issue. Review of batch records indicate no non-conformity associated with the referenced lot. As the impacted lot expired 11feb2015, no relevant device testing can be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00040 |
| MDR Report Key | 4821543 |
| Report Source | 01,05,06 |
| Date Received | 2015-06-05 |
| Date of Report | 2015-05-27 |
| Date of Event | 2014-09-05 |
| Date Mfgr Received | 2015-05-27 |
| Device Manufacturer Date | 2014-03-06 |
| Date Added to Maude | 2015-07-06 |
| 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 | MR. RYAN LEMELLE |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318582 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS LH |
| Generic Name | VIDAS LH TEST |
| Product Code | CEP |
| Date Received | 2015-06-05 |
| Catalog Number | 30406 |
| Lot Number | 1002870450 |
| Device Expiration Date | 2015-02-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX SA |
| Manufacturer Address | 5, RUE DES AQUEDUCS CRAPONNE, FR 69290 FR 69290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-05 |