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 2016-08-17 for VITEK? 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT 21347 manufactured by Biomerieux, Inc.
[52393195]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[52393196]
A customer in (b)(6) contacted biomerieux to report a misidentification of proprionibacterium acnes as atopium vaginae in association with the vitek 2 anc id test kit. The customer performed confirmatory testing via rapidana and obtained the result of proprionibacterium acnes. Proprionibacterium acnes was reported to the physician. The customer reported a delay (unknown duration) as a result of the retesting. There is no report from the hospital or treating physician that the occurrence lead to any adverse event related to the patient's state of health. Culture submittals were requested by biomerieux for internal investigation. An internal biomerieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[62547496]
A customer in (b)(6) contacted biom? Rieux to report a misidentification of propionibacterium acnes as atopobium vaginae in association with the vitek 2 anc id test kit. An internal biom? Rieux investigation was performed. The customer tested the isolate from brucella agar (oxoid) after incubating the strain for 18-72 hr under anaerobic conditions. Two (2) lab reports were submitted; both showing an excellent identification of atopobium vaginae. Lab report (b)(6) showed two (2) atypical reactions (ellm negative and nag positive). Lab report (b)(6) showed three (3) atypical negative reactions (ellm, phea, amani). An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain. Without the strain or raw data it's not possible to further evaluate the cause of the misidentification. On 01nov2016 ind/qc anc lot 244386840 met final qc release criteria. There were no issues observed on initial qc performance testing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2016-00097 |
| MDR Report Key | 5883802 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-08-17 |
| Date of Report | 2016-07-19 |
| Date Mfgr Received | 2016-07-19 |
| Device Manufacturer Date | 2016-01-16 |
| Date Added to Maude | 2016-08-17 |
| 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 | 2016-08-17 |
| Catalog Number | 21347 |
| Lot Number | 244386840 |
| Device Expiration Date | 2017-07-17 |
| 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 | 2016-08-17 |