MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-05-01 for VITEK? 2 GRAM POSITIVE ID TEST KIT 21342 manufactured by Biomerieux Inc..
[106980995]
A customer from (b)(6) notified biom? Rieux of misidentification results when testing two strains of staphylococcus aureus from minced meat with the vitek 2 gp id test kit (ref 21342). Vitek identified the strain as enterococcus faecium. Biochemical analysis provided by bbl crystal obtained the correct identification. When performing qc testing with s. Aureus atcc 25923, vitek 2 obtained the correct identification. The customer reported there was a delay in results of an unspecified length. There was no patient associated with these strains. Although this event occurred at an industry site, the same product, vitek 2 gp id test kit, is used in clinical testing as well. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00167 |
| MDR Report Key | 7475378 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-05-01 |
| Date of Report | 2018-08-01 |
| Date Mfgr Received | 2018-07-10 |
| Device Manufacturer Date | 2017-12-19 |
| Date Added to Maude | 2018-05-01 |
| 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. CANDACE MARTIN |
| 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 | 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 GRAM POSITIVE ID TEST KIT |
| Generic Name | VITEK? 2 GP ID TEST KIT |
| Product Code | LQL |
| Date Received | 2018-05-01 |
| Catalog Number | 21342 |
| Lot Number | 2420571103 |
| Device Expiration Date | 2019-06-20 |
| 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 | 2018-05-01 |