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 2017-01-06 for VITEK? 2 GN TEST KIT 21341 manufactured by Biomerieux, Inc.
[64128846]
A customer from (b)(6) reported to biom? Rieux a misidentification of klebsiella pneumoniae as klebsiella oxytoca (99%) in association with the vitek? 2 gn test kit. The isolate was tested with the filmarray? And was identified as klebsiella pneumonia, while testing with the vitek? 2 gn identified klebsiella oxytoca. The customer reported there was no impact to the patient. The isolate was requested from the customer. An internal biom? Rieux investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
[71638662]
An internal biom? Rieux investigation concluded the following: the submitted isolate was subcultured and testing included gn cards from the customer's lot and a random lot, in duplicate. Also tested was the api 20e test kit. All four gn cards tested resulted in excellent identifications of klebsiella pneumoniae. The api 20e gave a low discrimination identification of k. Pneumoniae 1/ k. Pneumoniae 2. Vitek 2 gn cards are performing as expected. A review of the customer's k. Oxytoca data (analysis time of 2 hours) against the expected reactions for k. Pneumoniae demonstrated 1 atypical positive reaction (iarl) contributing to the misidentification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2017-00005 |
| MDR Report Key | 6230884 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-06 |
| Date of Report | 2017-04-03 |
| Date Mfgr Received | 2017-03-07 |
| Date Added to Maude | 2017-01-06 |
| 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 | ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS 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 GN TEST KIT |
| Generic Name | VITEK? 2 GN TEST CARD |
| Product Code | JTO |
| Date Received | 2017-01-06 |
| Catalog Number | 21341 |
| Lot Number | 241385810 |
| Device Expiration Date | 2017-07-07 |
| 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 | 2017-01-06 |