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 2017-04-03 for VITEK? 2 ANC TEST KIT 21347 manufactured by Biomerieux, Inc.
[71596136]
A customer from (b)(6) reported to biom? Rieux a misidentification of an aerococcus sanguinis gram positive cocci urine sample, in association with the vitek? 2 anc test kit. The sample was tested twice with the anc card and the results were unidentified organism and anaerococcus prevotii. The isolate was cultured on cos (columbia sheep blood) media. The customer sent the sample to an external laboratory and the result was aerococcus sanguinis by maldi-toff. The customer stated the incorrect result of anaerococcus prevotii was reported to the physician but patient results and treatment was not affected. There was a 48 hour/ 72 hour delay for reporting results. The lab reports and isolate were requested from the customer. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00103 |
| MDR Report Key | 6453911 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-03 |
| Date of Report | 2017-07-03 |
| Date Mfgr Received | 2017-06-06 |
| Device Manufacturer Date | 2016-07-28 |
| Date Added to Maude | 2017-04-03 |
| 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 | 2017-04-03 |
| Catalog Number | 21347 |
| Lot Number | 2440062203 |
| ID Number | 03573026144364 |
| Device Expiration Date | 2018-01-27 |
| 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 | 2017-04-03 |