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 2017-02-23 for VITEK? 2 ANC TEST KIT 21347 manufactured by Biomerieux, Inc.
[68281131]
A customer from (b)(6) reported to biom? Rieux a misidentification of proponobacterium acnes in association with the vitek? 2 anc test kit. The customer reported the results received on vitek? 2 to be atobopium vaginae but expected the result to be proponobacterium acnes. The customer sent the strain to au chu de bordeaux but no results were obtained on malditoff brucker, although results were obtained by sequencing arn16s: proponiobacterium acnes. The customer reported that the incorrect results were not reported to a physician and did not impact patient results or treatment. There was a delay in reporting results. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[75954027]
A customer from france reported to biom? Rieux a misidentification of proponobacterium acnes in association with the vitek? 2 anc test kit. (b)(4). The customer submitted lab reports for evaluation. An investigation was performed. The customer set up the anc card from a 24 hour culture grown on columbia sheep blood agar under anaerobic conditions. Two anc lab reports were submitted showing an excellent identification of atobopium vaginae. Both lab reports showed two atypical negative reactions (ellm, arg) for an identification of proponobacterium acnes according to the anc knowledge base. Three lab reports were submitted for the quality control strain, corynebacterium striatum atcc baa-1293, which showed passing qc results. A review of quality records confirmed anc lot 244097720 had no issues with qc performance testing and met final qc release criteria. In conclusion, an increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain. Without the strain or raw data it's not possible to further evaluate the cause of the misidentification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2017-00062 |
| MDR Report Key | 6352237 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-23 |
| Date of Report | 2017-05-17 |
| Date Mfgr Received | 2017-04-18 |
| Device Manufacturer Date | 2016-05-04 |
| Date Added to Maude | 2017-02-23 |
| 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. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT 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 | 2017-02-23 |
| Catalog Number | 21347 |
| Lot Number | 244397720 |
| ID Number | 03573026144364 |
| Device Expiration Date | 2017-11-03 |
| 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 SAINT LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-23 |