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 2015-10-15 for VITEK? 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT 21347 manufactured by Biomerieux, Inc.
[28416100]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[28416101]
A customer in (b)(6) contacted biomerieux to report a discrepant association de biologie praticienne (abp) survey organism identification on the vitek 2 anaerobic and corynebacteria (anc) identification (id) test kit. Bacteroides fragilis was misidentified as bacteroides ureolyticus. There is no indication or report from the hospital to biomerieux that the discrepant result led to any adverse event related to a patient's state of health. No patient was directly associated with the abp survey result. Culture submittals have been requested by biomerieux for internal investigation. An internal biomerieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[33954528]
Biom? Rieux internal investigation was conducted with the patient isolate submitted by the customer. Testing performed: gram stain to confirm organism orientation; 16s sequencing; vitek? 2 anc id card (customer lot and random lot); vitek? Ms; api? 20a strip; rapid id32a strip. Testing results: gram coloration indicates presence of coccobacillus, gram negative; 16s sequencing provided result of bacteroides fragilis; vitek? Ms: bacteroides fragilis; rapid id 32a: bacteroides fragilis; api? 20a: bacteroides fragilis; vitek? 2 anc id card (both lots, customer and random) provided identification to bacteroides fragilis. The misidentification reported by the customer was not reproduced. The vitek? 2 anc id cards performed in accordance with specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2015-00069 |
| MDR Report Key | 5153769 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-10-15 |
| Date of Report | 2015-09-30 |
| Date Mfgr Received | 2015-09-30 |
| Device Manufacturer Date | 2014-05-03 |
| Date Added to Maude | 2015-10-15 |
| 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 | MR. RYAN LEMELLE |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318582 |
| 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 | 2015-10-15 |
| Catalog Number | 21347 |
| Lot Number | 244324540 |
| Device Expiration Date | 2015-11-02 |
| 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 | 2015-10-15 |