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 2017-04-28 for VITEK? 2 ANC TEST KIT 21347 manufactured by Biomerieux, Inc.
[74023152]
A customer in (b)(6) reported to biom? Rieux discrepant results associated with vitek? 2 anc test kit (reference 21347). The customer reported the vitek? 2 anc card results as anaerococcus prevotii but an alternative testing method vms results reported oligella urethralis. The customer reported that eleven (11) tests were run on the vitek? 2, ten (10) resulted in no identification and one (1) result was too noisy to give a result. The vitek? Instrument was fine-tuned and the customer reported the system was not working as expected. The identification results were normal and anaerococcus species not present in the vitek? 2. The customer reported using another method. The reference method used was sequencing, genus used the same method as the vitek? 2 but not the same species name. The analysis of new data from the customer (data from new tests) with next vitek? 2, (which contains 3 species of anaerococcus : anaerococcus prevotii, anaerococcus tetradius, anaerococcus vaginalis), the customer reported that the results again anaerococcus tetradius for two (2) of the eleven (11) tests with kb v3. 1 industry and kb v3. 2 (next kb) and 1 of the 11 tests with kb v3. 0 clinic. Culture submittals were requested by biom? Rieux. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00132 |
| MDR Report Key | 6529211 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-28 |
| Date of Report | 2017-07-25 |
| Date Mfgr Received | 2017-06-27 |
| Date Added to Maude | 2017-04-28 |
| 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 | 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 | 2017-04-28 |
| Model Number | 21347 |
| Lot Number | 244397720 |
| 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 | 2017-04-28 |