MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-06-09 for VIDAS? NT-PROBNP 2 30458 manufactured by Biomerieux, S.a..
[77459133]
A customer from (b)(6) reported to biom? Rieux a labeling discrepancy in association with the vidas? Nt-probnp 2 60 tests. The customer reported the label was covered by another label. The label pasted on the kit was for lot 1005161930. Upon examination of the kits, the product lot number of the strips was lot 1005578400. Biom? Rieux confirmed that the customer had received lot 1005578400 in (b)(6). An biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00132 |
| MDR Report Key | 6630803 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-09 |
| Date of Report | 2017-07-10 |
| Date Mfgr Received | 2017-06-12 |
| Device Manufacturer Date | 2017-03-17 |
| Date Added to Maude | 2017-06-09 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| 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? NT-PROBNP 2 |
| Generic Name | VIDAS? NT-PROBNP 2 |
| Product Code | NBC |
| Date Received | 2017-06-09 |
| Catalog Number | 30458 |
| Lot Number | 1005578400 |
| ID Number | 03573026229641 |
| Device Expiration Date | 2018-03-03 |
| 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, S.A. |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-09 |