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 2016-11-17 for VITEK 2 ANC TEST KIT 21347 manufactured by Biomerieux, Inc.
[60431413]
A customer in (b)(6) notified biom? Rieux of a misidentification associated with vitek? 2 anc test kit involving an external quality control sample ((b)(6)). The customer obtained a result of atopobium vaginae instead of propionibacterium acnes using the vitek? 2 anc card. Four (4) identifications were performed with the same result. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[68238403]
A second supplementary medwatch report is being submitted because fields b. 4 and g. 4 were erroneously omitted on the first supplement.
Patient Sequence No: 1, Text Type: N, H10
[68239353]
An internal biom? Rieux investigation was performed with results as follows:? Vitek? 2 anc test kit (lot 244390210): provided organism identification to the species propionibacterium acnes, as expected. ? Sequencing: provided organism identification to the species propionibacterium acnes, as expected. ? Vitek? Ms: provided organism identification to the species propionibacterium acnes, as expected. ? Api? 20a: provided organism identification to the species propionibacterium acnes, as expected. ? Rapid id32a: inacceptable profile. ? Api? Cotyne: doubtful profile. The investigation concluded the vitek? 2 anc test kit is performing as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2016-00184 |
| MDR Report Key | 6109073 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-11-17 |
| Date of Report | 2017-02-09 |
| Date Mfgr Received | 2017-01-20 |
| Date Added to Maude | 2016-11-17 |
| 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, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS 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 | VITEK 2 ANC TEST KIT |
| Generic Name | VITEK 2 ANC CARD |
| Product Code | JSP |
| Date Received | 2016-11-17 |
| Catalog Number | 21347 |
| Lot Number | 244386840 |
| Device Expiration Date | 2017-07-17 |
| 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, INC |
| Manufacturer Address | 595 ANGLUM ROAD ST. LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-17 |