MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-01-13 for VIDAS? MUMPS IGG ASSAY 30218 manufactured by Biomerieux Sa.
[35922827]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[35922828]
A customer in the united states reported a discrepancy in results with the vidas mumps igg test. There is no indication or report from the hospital to biomerieux that the associated results led to any adverse event related to a patient's state of health. Submittal of the patient sample has been requested. Biomerieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[39252578]
Biom? Rieux internal investigation was conducted. However, the customer did not comply with biom? Rieux request for sample submittal and the referenced product lot was already expired. Analysis of the manufacturing qc batch record for the referenced lot indicated no abnormality. As indicated in the instructions for use, vidas mumps igg performance does not claim 100% in term of specificity or sensitivity. Vidas mumps igg and arup use different testing methods; they are qualitative elfa test and semi-quantitative chemiluminescent test, respectively. Without the arup performance specifications (sensitivity and specificity) and the lack of third confirmatory method, it is not possible to determine which result is correct. The investigation concluded that no product performance issue was confirmed for the referenced lot of vidas mumps igg assay.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00008 |
| MDR Report Key | 5365077 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-01-13 |
| Date of Report | 2015-10-16 |
| Date Mfgr Received | 2015-10-16 |
| Device Manufacturer Date | 2015-02-12 |
| Date Added to Maude | 2016-01-13 |
| 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 | 3 |
| Event Location | 3 |
| 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 | BIOMERIEUX SA |
| Manufacturer Street | CHEMIN DE L ORME |
| Manufacturer City | MARCY L ETOILE, RHONE 69280 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS? MUMPS IGG ASSAY |
| Generic Name | VIDAS? MUMPS IGG ASSAY |
| Product Code | LJY |
| Date Received | 2016-01-13 |
| Catalog Number | 30218 |
| Lot Number | 1003758900 |
| Device Expiration Date | 2015-12-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-13 |