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 2018-01-10 for VITEK? 2 ANC TEST KIT 21347 manufactured by Biomerieux Inc..
[97736823]
A customer in (b)(6) notified biom? Rieux of the misidentification of a probioqual external quality control sample, 17ca2a, when testing with vitek? 2 anc test kit (ref 21347). The expected identification is corynebacterium urealyticum. The customer stated they tested twice with vitek 2. They initially obtained a result of "unidentified organism," and the second result was 99% clostridium group. There is no indication or report from the laboratory that the discrepant quality result led to any adverse event related to any patient's state of health. There was no patient associated with this quality control sample. A biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00016 |
| MDR Report Key | 7179165 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-10 |
| Date of Report | 2018-05-11 |
| Date Mfgr Received | 2018-04-17 |
| Device Manufacturer Date | 2017-04-10 |
| Date Added to Maude | 2018-01-10 |
| 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 | MR. JEFF SCANLAN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318694 |
| Manufacturer G1 | BIOMERIEUX INC. |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT 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 | 2018-01-10 |
| Catalog Number | 21347 |
| Lot Number | 2440318203 |
| Device Expiration Date | 2018-10-10 |
| 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 SAINT LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-10 |