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 2018-09-11 for VITEK? 2 GRAM NEGATIVE ID TEST KIT 21341 manufactured by Biomerieux Inc..
[120731029]
A customer from (b)(6) notified biom? Rieux of misidentification results when testing with the vitek? 2 gn id test kit (ref 21341). The customer tested a patient isolate from a stool sample with the gn card, lot 2410515203 and obtained an identification of pluralibacter gergoviae twice. This strain was tested with api and identified as shigella sonnei. Pcr also identified the strain as shigella. The customer repeated testing after cleaning the optics, and they obtained the correct identification of shigella sonnei. However, this was obtained with a different lot number, 2410555403. The customer confirmed the results were not released to the physician, and there was no impact on the patient treatment. They stated there was a delay in reporting the results of greater than 48 hours. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00351 |
| MDR Report Key | 7866424 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-11 |
| Date of Report | 2018-11-28 |
| Date Mfgr Received | 2018-10-30 |
| Device Manufacturer Date | 2018-04-25 |
| Date Added to Maude | 2018-09-11 |
| 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. CANDACE MARTIN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD 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 NEGATIVE ID TEST KIT |
| Generic Name | VITEK? 2 GN ID TEST KIT |
| Product Code | LQM |
| Date Received | 2018-09-11 |
| Catalog Number | 21341 |
| Lot Number | 2410515203 |
| Device Expiration Date | 2019-04-25 |
| 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 | 2018-09-11 |