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 2015-07-09 for VIDAS VARICELLA-ZOSTER IGG 30217 manufactured by Biom?rieux Sa.
[6072815]
A customer reported to biom? Rieux a discrepant result on the vidas vzg test kit. The sample was collected from a pregnant woman and gave a negative result when tested with the vidas vzg kit. The sample was sent to the leeds reference laboratory and returned a positive result. The patient did not receive any treatment. The treatment decision was based on the reference laboratory test results. Vidas varicella-zoster igg (vzg) is an automated qualitative test for use on the instruments of the vidas family, for the detection of igg antibodies to varicella zoster virus in human serum using the elfa (enzyme linked fluorescent assay) technique. Vidas vzg is intended as an aid in the determination of immunological experience with varicella zoster virus. An internal investigation has been initiated within biom? Rieux.
Patient Sequence No: 1, Text Type: D, B5
[31934272]
10 positive or equivocal near positivity samples were tested on retain samples from lot 1003778670. The 10 samples gave appropriate results and are within specification. Compared to the quality control results obtained during lot release, lot 1003778670 has not changed. In conclusion, the investigation showed that there is no quality drift for lot 1003778670 and is within performance specifications as defined within the package insert.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00055 |
| MDR Report Key | 4901403 |
| Report Source | 01,05,06 |
| Date Received | 2015-07-09 |
| Date of Report | 2015-07-03 |
| Date Mfgr Received | 2015-07-03 |
| Date Added to Maude | 2015-07-09 |
| 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 | 5, RUE DES AQUEDUCS |
| Manufacturer City | CRAPONNE, FR 69290 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69290 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS VARICELLA-ZOSTER IGG |
| Generic Name | ENZYME LINKED IMMUNOABSORBENT ASSAY, VARICELLAZOSTER, |
| Product Code | LFY |
| Date Received | 2015-07-09 |
| Catalog Number | 30217 |
| Lot Number | 1003778670 |
| Device Expiration Date | 2015-11-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-07-09 |