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 2016-09-30 for VITEK? 2 GRAM NEGATIVE ID TEST KIT 21341 manufactured by Biomerieux, Inc.
[56106469]
A customer notified biomerieux that they had mis-identifications when using the vitek 2 gram negative id test kit. A patient sample was identified by the test kit as pseudomonas putida. Api identified the organism to be kleb pneumo. When specifically asked, the customer noted no injury or death happened as a result of the mis-identifications. An investigation will be initiated by biomerieux to investigate this event.
Patient Sequence No: 1, Text Type: D, B5
[62562210]
A customer notified biomerieux that they had mis-identifications when using the vitek? 2 gram negative id test kit. An internal biom? Rieux investigation was performed. The submitted isolate was subcultured and testing included two (2) gn cards from the customer lot, two (2) cards from a random lot, and the api? 20e. All four (4) gn cards tested gave very good identifications of klebsiella pneumoniae. The api? 20 e gave a good identification of klebsiella pneumoniae (94%). Review of the customer's pseudomonas luteola data against expected reactions for klebsiella pneumoniae demonstrated five (5) atypical negative reactions (ado, bglu, dman, agal and phos) contributing to the mis-identification. An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain. Vitek? 2 cards are performing as expected and no further action is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2016-00139 |
| MDR Report Key | 5991713 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-09-30 |
| Date of Report | 2016-08-31 |
| Date Mfgr Received | 2016-08-31 |
| Date Added to Maude | 2016-09-30 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD 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 GRAM NEGATIVE ID TEST KIT |
| Generic Name | VITEK? 2 GRAM NEGATIVE ID TEST KIT |
| Product Code | LRH |
| Date Received | 2016-09-30 |
| Catalog Number | 21341 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-09-30 |