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 2016-07-28 for VITEK? 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT 21347 manufactured by Biomerieux, Inc.
[50624926]
(b)(4). Biom? Rieux internal investigations were conducted for events #1 and #2. For event #3, investigation results are pending. Event #1 and event #2: on the abp qc survey, strain br1, we confirmed the identification expected to trueperella pyogenes with vitek? Ms (ivd v2. 0 ) and api coryne. We obtained on anc cards (customer lot + random lot), a low discriminated profile between trueperella pyogenes and actinomyces odontolyticus with 2 tests against / species. Atypical biochemical profile of the strain lead to a low level of identification on anc card. It is recommended in this case to perform complementary test to conclude. We did not duplicate the misidentification obtained by customer. We observed that internal biochemical profile is similar except for 2 tests borderline (+) instead of positive, more in favor of trueperella pyogenes. The anc cards are performing as expected and no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[50624927]
This report summarizes 3 malfunction events. (b)(4). A review of events indicated that testing via vitek 2 anaerobic and corynebacteria (anc) identification (id) test kit resulted in organism misidentifications to include: actinomyces odontolyticus instead of trueperella pyogenes involving a quality control sample. Actinomyces odontolyticus instead of trueperella pyogenes involving a quality control sample. Corynebacterium minutissimum instead of corynebacterium diphtheria involving a patient sample. For all three (3) events, there was no indication or report of adverse events or negative patient due to the discrepant results. For events #1 and #2, the customers indicated the strains were not available for submittal and for event #3, the isolate was requested.
Patient Sequence No: 1, Text Type: D, B5
[55587446]
This report was initially submitted following notification that a customer in the united states reported an occurrence of a misidentification of corynebacterium diphtheria as corynebacterium minutissimum in association with the vitek? 2 anc id test kit. Biom? Rieux investigation was conducted. Testing of the isolate included one (1) anc id card from the same lot tested by the customer and one (1) anc id card from a random lot. Both anc id cards provided an organism identification of corynebacterium minutissimum. Since the centers for disease control (cdc) determined the organism to be corynebacterium diphtheria, no further internal testing was performed. Review of the internal raw data against the expected reactions for corynebacterium diphtheriae show there to be two (2) atypical negative reactions (ellm, mte) which contributed to the misidentification. The overall investigation concluded the submitted strain exhibits atypical growth behavior for the vitek? 2 anc id testing method. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2016-00071 |
| MDR Report Key | 5828863 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-07-28 |
| Date of Report | 2016-05-31 |
| Date Mfgr Received | 2016-05-31 |
| Device Manufacturer Date | 2015-03-12 |
| Date Added to Maude | 2016-07-28 |
| 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 | 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 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT |
| Generic Name | VITEK? 2 ANC CARD |
| Product Code | JSP |
| Date Received | 2016-07-28 |
| Catalog Number | 21347 |
| Lot Number | 244355810 |
| Device Expiration Date | 2016-09-10 |
| 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 | 1. Life Threatening | 2016-07-28 |