MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-05-25 for VITEK? 2 GRAM POSITIVE ID TEST KIT 21342 manufactured by Biomerieux Inc..
[109900168]
A customer from the united states notified biom? Rieux of the misidentification of a aerococcus urinae strain, isolated from a patient urine culture specimen, when testing with the vitek? 2 gp id test kit. Initial vitek 2 testing obtained a result of gemella sanguinis. Repeat testing obtained an "unidentified" result. The customer sent the isolate to mayo medical laboratories for confirmation of the identification, which obtained a result of aerococcus urinae. 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. A biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00199 |
| MDR Report Key | 7544207 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-25 |
| Date of Report | 2018-07-10 |
| Date Mfgr Received | 2018-06-14 |
| Device Manufacturer Date | 2018-03-02 |
| Date Added to Maude | 2018-05-25 |
| 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 | 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 GRAM POSITIVE ID TEST KIT |
| Generic Name | VITEK? 2 GP ID TEST KIT |
| Product Code | LQL |
| Date Received | 2018-05-25 |
| Catalog Number | 21342 |
| Lot Number | 2420644203 |
| Device Expiration Date | 2019-09-01 |
| 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 | 2018-05-25 |