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 2017-09-29 for VITEK? 2 ANC TEST KIT 21347 manufactured by Biomerieux, Inc.
[89501948]
A customer from the united states reported to biom? Rieux a misidentification of a propionibacterium cap survey sample in association with the vitek? 2 anc test kit. The customer reported they identified the sample as peptostreptococcus and the expected result was propionibacterium. The customer stated a gram stain was performed but the organism was questionable. The customer entered sample data as rods in the vitek? 2, and the identification was clostridium low discrimination. When they selected cocci, a result of peptostreptococcus (95%) was received. The customer stated the cap survey sample was rehydrated and plated in anaerobic conditions for approximately four days, then subbed to a daughter plate from which the vitek? 2 test was performed. No alternative method was performed. The isolate is not available from the customer. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00322 |
| MDR Report Key | 6904411 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-29 |
| Date of Report | 2017-11-10 |
| Date Mfgr Received | 2017-10-17 |
| Device Manufacturer Date | 2016-06-24 |
| Date Added to Maude | 2017-09-29 |
| 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 | 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 ANC TEST KIT |
| Generic Name | VITEK? 2 ANC TEST CARD |
| Product Code | JSP |
| Date Received | 2017-09-29 |
| Catalog Number | 21347 |
| Lot Number | 2440028203 |
| ID Number | 03573026144364 |
| Device Expiration Date | 2017-12-24 |
| 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 | 2017-09-29 |