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 2018-07-17 for VITEK?2 GP TEST KIT 21342 manufactured by Biomerieux, Inc.
[114807024]
A customer in (b)(6) notified biomerieux of a misidentification associated with vitek? Gp test kit (reference 21342). The customer reported observing an incorrect identification of globicatella sanguinis for an actinotignum schaalii eeq ctcb survey strain. The strain was tested on three (3) different agar plates: cna (presence of colonies), chocolate (presence of colonies), cps (absence of colonies). The customer reported not performing routine quality control checks. A gram stain was performed prior to card set up and found gram-positive cocci and catalase negative. As indicated in the ctcb survey instructions actinotignum schaalii is a "short bacillus, almost cocci-like" which could explain the "cocci gram +" result and consequently the choice of the gp id card. This organism should be tested with the vitek 2 anc test kit. There is no indication or report from the laboratory to biom? Rieux that the discrepant result led to any adverse event related to any patient's state of health. There was no patient directly associated with the eeq survey strain. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00258 |
| MDR Report Key | 7694062 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-17 |
| Date of Report | 2018-09-18 |
| Date Mfgr Received | 2018-08-23 |
| Device Manufacturer Date | 2017-11-29 |
| Date Added to Maude | 2018-07-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. TIFFANY HALL |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| 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 | LQM |
| Date Received | 2018-07-17 |
| Catalog Number | 21342 |
| Lot Number | 2420551103 |
| Device Expiration Date | 2019-05-31 |
| 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 | 2018-07-17 |