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 2018-07-10 for VITEK? 2 GP TEST KIT 21342 manufactured by Biomerieux, Inc.
[113882178]
A customer from the united states reported a misidentification of staphylococcus aureus patient strain (wound culture) as staphylococcus pseudintermedius in association with the vitek? 2 gp test kit (lot 2420614403). The customer obtained the identification of s. Pseudintermedius using the gp card and their latex test was positive. Alternate testing was done by an external lab that tested the strain by vitek 2, vitek ms, and microscan in which all methods identified the organism as s. Aureus. The customer reported that to their knowledge there was no delay, there was no unnecessary patient treatment or procedures and no notification from a physician about the result(s). 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. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00248 |
| MDR Report Key | 7675818 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-10 |
| Date of Report | 2018-08-29 |
| Date Mfgr Received | 2018-08-02 |
| Device Manufacturer Date | 2018-01-31 |
| Date Added to Maude | 2018-07-10 |
| 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 | MS. DEBRA BROYLES |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318805 |
| 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 GP TEST KIT |
| Generic Name | VITEK? 2 GP TEST KIT |
| Product Code | LQL |
| Date Received | 2018-07-10 |
| Catalog Number | 21342 |
| Lot Number | 2420614403 |
| Device Expiration Date | 2019-08-02 |
| 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 | 2018-07-10 |