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 2018-04-25 for VITEK? 2 ANC TEST KIT 21347 manufactured by Biomerieux Inc..
[107086820]
A customer in (b)(6) reported a misidentification of corynebacterium macginleyi from a patient isolate (eye sore), as proponobacterium acnes in association with the vitek? 2 anc test kit 20cards (lot 2440440103). The customer stated that while testing a gram positive bacillus strain from the patient isolate on cos and can media, a growth was observed that suggested a potential corynebacterium species. The customer tested the strain on the anc card, and an identification of proponobacterium acnes (95%) was obtained. The customer sent the strain to the national reference center for testing and the result was corynebacterium macginleyi by mass spectrometry. No incorrect result was reported to the clinician, but there was a 48 hour delay in reporting results due to complementary testing. Corynebacterium macginleyi species is not a claimed species for vitek 2 anc cards. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00162 |
| MDR Report Key | 7461442 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-04-25 |
| Date of Report | 2018-08-15 |
| Date Mfgr Received | 2018-07-19 |
| Device Manufacturer Date | 2017-08-10 |
| Date Added to Maude | 2018-04-25 |
| 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 | MS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM RD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| 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 TEST KIT |
| Product Code | JSP |
| Date Received | 2018-04-25 |
| Catalog Number | 21347 |
| Lot Number | 2440440103 |
| Device Expiration Date | 2019-02-09 |
| 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 | 2018-04-25 |