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 2016-08-18 for VITEK? 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT 21347 manufactured by Biomerieux, Inc.
[52726643]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[52726644]
A customer in france contacted biomerieux to report a misidentification of bacteroides ovatus (microbiologics atcc 1296) as prevotella disiens in association with the vitek 2anc id test kit. Per microbiologics (mbl) recommendation, the strain was incubated using cos media in an anaerobic atmosphere and obtained colony growth after 48 hours. There is no report from the customer that the occurrence lead to any adverse event related to any patient's state of health. Culture submittals were requested by biomerieux for internal investigation. An internal biomerieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[59248010]
This report was initially submitted following notification that a customer france reported a misidentification of bacteroides ovatus (microbiologics atcc? Baa-1296) as prevotella disiens in association with the vitek? 2 anc id test kit. There were 3-15 negative (-) well reactions associated with the misidentifications. Biom? Rieux investigation was conducted. Using the internal reference strain of atcc? Baa-1296 as well as the strain submitted by the customer, investigational testing was performed from cultures incubated on cba plates, in anaerobic environment, for two different incubation times (24 and 48 hours). Internal reference strain produced the expected result of bacteroides ovatus for isolates from both incubation times. Customer strain produced expected result of bacteroides ovatus for one test, and produced three (3) discrepant well reactions (+) for the second test. The investigation did not duplicate the customer results, but obtained one time, three (3) discrepant positive (+) well reactions ((b)(4)) with the customer strain, on the random anc id lot (244390210). Anc id test kit lot 244366910 met final qc release criteria. There were no issues observed on qc performance testing. There were no ncmr's written against this lot. Ncmr's were reviewed for the last 13 months and there were no ncmr's written for misidentification of atcc baa-1296 bacteroides ovatus. The investigation concluded the vitek? 2 anc id test kit is performing as intended.
Patient Sequence No: 1, Text Type: N, H10
[59248011]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2016-00099 |
| MDR Report Key | 5885945 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-08-18 |
| Date of Report | 2016-07-19 |
| Date Mfgr Received | 2016-07-19 |
| Device Manufacturer Date | 2016-01-16 |
| Date Added to Maude | 2016-08-18 |
| 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 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT |
| Generic Name | VITEK? 2 ANC CARD |
| Product Code | JSP |
| Date Received | 2016-08-18 |
| Catalog Number | 21347 |
| Lot Number | 244366910 |
| Device Expiration Date | 2016-12-30 |
| 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 | 2016-08-18 |