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 2018-05-21 for VITEK? 2 GP TEST KIT 21342 manufactured by Biomerieux Inc..
[109374590]
A customer in (b)(6) reported a misidentification of aerococcus urinae as granulicatella adiacens in association with the vitek? 2 gp test kit. On (b)(6) 2018 the customer suspected aerococcus urinae but the gp card identified granulicatella adiacens (98%). The isolate was sent to the hospital on (b)(6) 2018 for identification by mass spectrometry, and the result received on (b)(6) was aerococcus urinae. There was a delay greater than 24 hours for reporting results. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. Later, the customer retested and the result was low discrimination between a urinae and g. Adiacens. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00194 |
| MDR Report Key | 7531113 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-21 |
| Date of Report | 2018-09-06 |
| Date of Event | 2018-04-20 |
| Date Mfgr Received | 2018-08-09 |
| Device Manufacturer Date | 2017-11-06 |
| Date Added to Maude | 2018-05-21 |
| 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. DEBRA BROYLES |
| 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 GP TEST KIT |
| Generic Name | VITEK? 2 GP TEST KIT |
| Product Code | LQL |
| Date Received | 2018-05-21 |
| Catalog Number | 21342 |
| Lot Number | 2420528103 |
| Device Expiration Date | 2019-05-08 |
| 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 | 2018-05-21 |