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 2017-10-18 for VITEK? 2 ANC TEST KIT 21347 manufactured by Biomerieux, Inc.
[90592939]
An investigation was performed. The cap d-10 survey specimen was not graded due to the lack of participant and referee consensus. Referees demonstrated 49. 2 % and participants 56. 2 % consensus for correct identification of all organisms. The bmx internal cap d-10 strain was rehydrated and subcultured under anaerobic conditions. Testing included individual organism suspensions on anc cards from four (4) different lots, in duplicate. Testing was also performed with vitek? Ms. The eight (8) anc cards tested resulted in low discrimination identifications of multiple clostridium species, not the expected result. The vitek? Ms resulted in the expected identification of propionibacterium granulosum (99. 5%). A review of customer's results against expected reactions for p. Granulosum, demonstrated several atypical negative reactions (ellm, pyra, arg, pvate, amani, drib). Many survey participants additionally entered atypical positive morphology (cocci) according to the anc knowledge base all contributing to the misidentification. An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain. The investigation concluded the submitted isolate has an atypical biochemical profile.
Patient Sequence No: 1, Text Type: N, H10
[90592940]
A customer from the united states reported to biom? Rieux a misidentification of an ungraded cap survey sample (simulated joint tissue) in association with the vitek? 2 anc test kit. The sample was identified as peptostreptococcus anaerobius with the vitek? 2 anc card and was reported. The customer was informed the correct identification was propionibacterium granulosum. The customer then repeated the anc test and the result was low discrimination organism. There was no patient involvement as this event was for a survey sample. The customer submitted the lab reports for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00342 |
| MDR Report Key | 6959339 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-18 |
| Date of Report | 2017-10-18 |
| Date Mfgr Received | 2017-09-22 |
| Date Added to Maude | 2017-10-18 |
| 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 | 2017-10-18 |
| Catalog Number | 21347 |
| ID Number | 03573026144364 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-10-18 |