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 2018-05-09 for VITEK? 2 ANC TEST KIT 21347 manufactured by Biomerieux Inc..
[108288805]
A customer from malaysia reported a misidentification of corynebacterium diphtheriae from a throat specimen in association with the vitek? 2 anc test kit (lot 2440422103). A customer first identified c. Diphtheriae with a high confidence level using api? Coryne. The isolate was then sent to a second customer for confirmation using vitek? 2. The isolate was tested multiple times with the anc card, and various identifications were obtained: c. Ulcerans , low discrimination to c. Amycolatum and atopobium vaginae, unidentified, and low discrimination to c. Amycolatum and c. Diphtheriae. The first customer then retested the isolate with the bd bbl? Crystal? Identification system which resulted in c. Diphtheria (99%). The customer stated the result of c. Diphtheria was reported to the clinician. The customer reported that there was no impact to patient results or treatment. The local field application specialist (fas) tested the isolate at the customer site and received a low discrimination to c. Amycolatum and a. Vaginae with the vitek 2. The fas then tested the isolate at another customer site and their own lab, with vitek 2 and vitek ms instruments. The vitek 2 results were low discrimination to c. Amycolatum and a. Vaginae, and also a. Vaginae at 93%. The vitek ms result was c. Diphtheriae at 99. 9%. The isolate was also tested with api coryne in duplicate, and both tests gave a doubtful profile. An investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00181 |
| MDR Report Key | 7500669 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-09 |
| Date of Report | 2018-07-19 |
| Date Mfgr Received | 2018-06-28 |
| Device Manufacturer Date | 2017-07-23 |
| Date Added to Maude | 2018-05-09 |
| 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 | MS. DEBRA BROYLES |
| 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 ANC TEST KIT |
| Generic Name | VITEK? 2 ANC TEST KIT |
| Product Code | JSP |
| Date Received | 2018-05-09 |
| Catalog Number | 21347 |
| Lot Number | 2440422103 |
| Device Expiration Date | 2019-01-22 |
| 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 | 2018-05-09 |