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 2017-01-06 for VITEK? 2 GRAM NEGATIVE TEST KIT 21341 manufactured by Biomerieux, Inc.
[64052844]
A customer in the united states notified biom? Rieux of a misidentification associated with the vitek? 2 gram negative test kit (reference 21341) involving a urine sample. The customer reported the vitek? 2 gn test kit identified the organism as proteus hausari; however, the sample was sent to api who identified the sample as proteus vulgaris. There is no indication that incorrect results were reported and the customer did not report negative patient impact or adverse events associated with the discrepancy. Culture submittals were requested by biom? Rieux. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[66254192]
This report was initially submitted following notification that a customer in the united states reported the occurrence of a low discrimination identification of proteus penneri / proteus hauseri in association with the vitek? 2 gram-negative (gn) identification (id) test kit (card). The expected identification for this api? Survey organism (api proficiency urine ur-11) was proteus vulgaris. Investigational testing api? Survey organism included: - vitek? 2 gn id cards [two cards each for four (4) customer lots, one (1) random lot]: two (2) of the customer lots (4 cards total) provided a low discrimination call of proteus penneri / proteus hauseri. The remaining two (2) customer lots and the random lot (6 cards total) provided a low discrimination call of proteus penneri / proteus pneumotropica. - api? 20e: identified proteus vulgaris group. - vitek? Ms: low discrimination call of proteus penneri / proteus vulgaris. As the organism is indole-positive, the vitek? Ms call of proteus vulgaris would be correct. The investigation concluded the api? Survey organism has an atypical biochemical profile for analysis by the vitek? 2 gn knowledge base.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2017-00006 |
| MDR Report Key | 6228614 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-01-06 |
| Date of Report | 2016-12-06 |
| Date Mfgr Received | 2016-12-06 |
| 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 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 GRAM NEGATIVE TEST KIT |
| Generic Name | VITEK? 2 GRAM NEGATIVE TEST KIT |
| Product Code | JTO |
| Date Received | 2017-01-06 |
| Catalog Number | 21341 |
| Lot Number | 241391440 |
| Device Expiration Date | 2017-09-01 |
| 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 ST. LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-06 |