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 2018-01-12 for VITEK? 2 ANC TEST KIT 21347 manufactured by Biomerieux Inc..
[97741607]
An internal biom? Rieux investigation was performed with results as follows: the biom? Rieux internal cap d-10 strain was rehydrated and subcultured under anaerobic conditions. Testing included individual organism suspensions on anc cards from four different lots, in duplicate, and the vitek? Ms. Exper/essay 5491/108 the eight (8) anc cards tested resulted in low discrimination identifications of multiple clostridium species, not the expected result. Testing with the vitek? Ms resulted in the expected identification of p. Granulosum with a 99. 5%confidence value. Review of the customers p. Anaerobius results against expected reactions for p. Granulosum demonstrated six atypical negative reactions (ellm, pyra, arg, pvate, amani, drib) and atypical positive morphology (gpc) according to the anc knowledge base and contributing to the misidentification. The customer reports a result of unidentified when entering morphology as gpr but this lab report was not saved for submittal. An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain. Quality system review of the most recent quarterly trend report, 2017 q2, did not identify this complaint as a systemic quality issue. This is an atypical strain.
Patient Sequence No: 1, Text Type: N, H10
[97741608]
A customer in the united states notified biom? Rieux of discrepant results associated with vitek? 2 anc test kit (reference 21347). The customer reported that they missed cap d-b sample d10. Customer reported peptostreptococcus anaerobius based on a coccobacilli nomenclature, but should have been propionibacterium acnes (old nomenclature) or cutibacterium acnes (new nomenclature) using a bacilli morphology. The customer repeated on their second swab with bacilli morphology and got low discrimination with several clostridium species. Bacilli morphology did not show until day seven (7) of incubation. Customer tested at 48 hours after subculturing two times. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00022 |
| MDR Report Key | 7185432 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-12 |
| Date of Report | 2018-01-12 |
| Date Mfgr Received | 2017-12-13 |
| Device Manufacturer Date | 2016-12-15 |
| Date Added to Maude | 2018-01-12 |
| 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 | ST. 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 | 2018-01-12 |
| Catalog Number | 21347 |
| Lot Number | 2440202103 |
| Device Expiration Date | 2018-06-16 |
| 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 SAINT LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-12 |