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 2016-11-04 for VITEK? 2 ANC ID TEST KIT 21347 manufactured by Biomerieux, Inc.
[59225849]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[59225850]
A pharmaceutical customer in (b)(6) contacted biomerieux to report a misidentification of corynebacterium imitans as corynebacterium diphtheriae in association with the vitek 2 anc identification (id) test kit. Repeat testing obtained the same results. Alternate method testing microseqid (molecular) obtained the corynebacterium imitans result. The customer stated the discrepant anc id results were not reported to the physician; therefore, these results did not affect patient treatment. Culture submittal was requested from the customer; the isolate is no longer available. Biomerieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[63667108]
A pharmaceutical customer in (b)(6) contacted biom? Rieux to report a misidentification of corynebacterium imitans as corynebacterium diphtheriae in association with the vitek? 2 anc identification (id) test kit. An internal biom? Rieux investigation was performed. The vitek? 2 anc card does not claim c. Imitans. The following limitation appears in the product labeling: newly described or rare species may not be included in the anc database. Selected species will be added as strains become available. Testing of unclaimed species may result in an unidentified result or a misidentification. It should also be noted that the proper incubation temperature for testing in the vitek? 2 anc card is 35-37c. On 21nov2016 industrialization vitek? 2 anc lot 244394540 met final qc release criteria. There were no issues observed on initial qc performance testing
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2016-00164 |
| MDR Report Key | 6078541 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-11-04 |
| Date of Report | 2016-10-05 |
| Date of Event | 2016-08-30 |
| Date Mfgr Received | 2016-10-05 |
| Device Manufacturer Date | 2016-03-02 |
| Date Added to Maude | 2016-11-04 |
| 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 ID TEST KIT |
| Generic Name | VITEK? 2 ANC ID TEST KIT |
| Product Code | JSP |
| Date Received | 2016-11-04 |
| Catalog Number | 21347 |
| Lot Number | 244394540 |
| Device Expiration Date | 2017-10-02 |
| 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 | 2016-11-04 |