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 2018-02-14 for VITEK? 2 ANC TEST KIT 21347 manufactured by Biomerieux, Inc.
[100255436]
A customer from france reported a misidentification for an external quality control sample (ctcb 174-2) in association with the vitek? 2 anc test kit (lot 2440285403). Strain 174-2 is described in the ctcb report 174 as, "isolated bacteria from appendicular pus of a 9 years old child. " the customer stated the anc card twice identified actinomyces odontolyticus at 94% and 95%, however, the expected result was eikenella corrodens. The customer reported using multiple aerobic, anaerobic and microaerophilic blood agars, and obtained growth in the aerobic and microaerophilic blood agar. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00071 |
| MDR Report Key | 7269916 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-14 |
| Date of Report | 2018-07-09 |
| Date Mfgr Received | 2018-06-07 |
| Device Manufacturer Date | 2017-03-08 |
| Date Added to Maude | 2018-02-14 |
| 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 KIT |
| Product Code | JSP |
| Date Received | 2018-02-14 |
| Catalog Number | 21347 |
| Lot Number | 2440285403 |
| ID Number | 03573026144364 |
| Device Expiration Date | 2018-09-07 |
| 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 | 2018-02-14 |