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 2017-06-29 for VITEK? 2 ANC TEST KIT 21347 manufactured by Biomerieux, Inc.
[78984411]
The biom? Rieux internal lyophilized cap sample d-04 was reconstituted and subbed onto anaerobic cdc agar, which was incubated under anaerobic conditions for 24 hr. Testing was performed on 3 different anc lots. Vitek? Ms testing was also performed. On all 3 card lots tested, an excellent id (99%) of c. Septicum was obtained. Vitek? Ms also identified the organism as c. Septicum, with a 99. 9% confidence value. A comparison of customer card reaction results for c. Perfrigens against expected reaction results for c. Septicum showed 10 atypical positive reactions (leua, dglu, dmne, dmal, sac, nag, ure, arg, pvate, phos) and 2 atypical negative reactions (bgali, bdfuc) which led to the misidentification. It should be noted that the d-04 sample contained 2 organisms: c. Septicum and s. Aureus. The presence of s. Aureus in the sample in addition to the c. Septicum may have resulted in the misidentification on the anc cards. When customer lab reports with the incorrect ids of c. Clostridioforme were examined, it was noted that a "gram negative" result was entered for offline testing instead of "gram positive". This resulted in c. Clostridioforme being identified instead of c. Septicum. In some of these cases, there was also one atypical negative result (bdfuc) when compared to expected reaction results for c. Septicum. When customer lab reports with the incorrect id of c. Chauvoei were examined, it was noted that the offline gram testing result was not entered, and there was also 1 atypical negative reaction (bdfuc) when compared to expected results for c. Septicum. Vitek? 2 anc test cards are performing as expected and no further action is necessary.
Patient Sequence No: 1, Text Type: N, H10
[78984412]
A customer from the united states reported to biom? Rieux a misidentification of a clostridium septicum cap survey sample as clostridium perfrigens in association with the vitek? 2 anc test kit. The customer reported that both survey swabs were identified as clostridium perfrigens. The expected cap survey identification was clostridium septicum. There was no patient involvement as this was a survey sample. The customer submitted lab reports from the testing of both swabs and the cap summary report for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00206 |
| MDR Report Key | 6677740 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-29 |
| Date of Report | 2017-06-29 |
| Date Mfgr Received | 2017-06-02 |
| Device Manufacturer Date | 2016-10-12 |
| Date Added to Maude | 2017-06-29 |
| 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 | 2017-06-29 |
| Catalog Number | 21347 |
| Lot Number | 2440138103 |
| ID Number | 03573026144364 |
| Device Expiration Date | 2018-04-13 |
| 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 | 2017-06-29 |