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 2018-07-10 for VITEK? 2 GRAM POSITIVE ID TEST KIT 21342 manufactured by Biomerieux Inc..
[113881813]
A customer from (b)(6) notified biom? Rieux of the misidentification of staphylococcus aureus when testing with vitek 2 gp id test kit. The customer tested a blood culture isolate twice with the vitek 2 gp id card and each time obtained an identification of staphylococcus pseudintermedius. The customer reported that the following conventional testing methods were performed and led them to suspect staphylococcus aureus: dnase+, prolab staph latex agglutination+, coagulase+, pyr-. The isolate was sent to phl reference lab and was identified as staphylococcus aureus using tube coagulase and maldi testing. There is no indication or report from the laboratory 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 | 1950204-2018-00249 |
| MDR Report Key | 7675613 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-10 |
| Date of Report | 2018-09-06 |
| Date Mfgr Received | 2018-08-07 |
| Device Manufacturer Date | 2017-12-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| 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 | 2018-07-10 |
| Catalog Number | 21342 |
| Lot Number | 2420582103 |
| Device Expiration Date | 2019-07-01 |
| 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 | 2018-07-10 |