MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-21 for VIDAS? MUMPS IGG ASSAY 30218 manufactured by Biomerieux, Sa.
[101057352]
A customer from the united states reported a false positive result for a cap survey sample in association with vidas? Mumps igg 60tests. On (b)(6) 2017, the customer tested the survey sample with vidas mumps igg and obtained a positive result when the expected result was negative. The sample was retested on (b)(6) 2018 and was also positive. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00018 |
| MDR Report Key | 7286082 |
| Date Received | 2018-02-21 |
| Date of Report | 2018-04-23 |
| Date of Event | 2017-10-31 |
| Date Mfgr Received | 2018-03-29 |
| Device Manufacturer Date | 2017-06-07 |
| Date Added to Maude | 2018-02-21 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX, SA |
| Manufacturer Street | 376 CHEMIN DE L'ORME |
| Manufacturer City | MARCY L'ETOILE, 69280 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VIDAS? MUMPS IGG ASSAY |
| Generic Name | VIDAS? MUMPS IGG ASSAY |
| Product Code | LJY |
| Date Received | 2018-02-21 |
| Catalog Number | 30218 |
| Lot Number | 1005750680 |
| Device Expiration Date | 2018-04-13 |
| 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 | 376 CHEMIN DE L'ORME MARCY L'ETOILE, 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-21 |