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 2017-03-07 for VITEK? 2 GN TEST KIT 21341 manufactured by Biomerieux, Inc.
[69330703]
A customer from the united states reported to biom? Rieux a misidentification of an escherichia coli urine sample as shigella sonnei in association with the vitek? 2 gn test kit. The customer reported the isolate was tested four (4) times with vitek? 2 gn and received an identification of shigella sonnei. The isolate was sent to a state laboratory for serology testing (maldi-tof) and the isolate was determined to be escherichia coli. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. The test reports were requested from the customer. An internal biom? Rieux investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
[73933136]
A customer from the united states reported to biom? Rieux a misidentification of an escherichia coli urine sample as shigella sonnei in association with the vitek? 2 gn test kit. An internal biom? Rieux investigation was performed. Testing included both a customer lot and a random lot of vitek? 2 gn cards. Api? 20 e was also performed. All cards tested gave an excellent id (99%) of s. Sonnei. Api? 20 e, however, gave a good identification (92. 3%) of e. Coli. A comparison of expected reaction results for e. Coli resulted in three (3) atypical negative reactions (dsor, phos, ldc), which led to the misidentification. It should be noted that, when an identification of shigella is made by vitek? 2 gn cards, an analysis message of "confirm by serological tests" is given. A complaint history review was completed for this issue during the last 13 month timeframe with no implication of a trend. Root cause: atypical strain.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2017-00081 |
| MDR Report Key | 6385695 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-07 |
| Date of Report | 2017-04-18 |
| Date Mfgr Received | 2017-03-23 |
| Device Manufacturer Date | 2016-07-25 |
| Date Added to Maude | 2017-03-07 |
| 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 GN TEST KIT |
| Generic Name | VITEK? 2 GN TEST CARD |
| Product Code | JTO |
| Date Received | 2017-03-07 |
| Catalog Number | 21341 |
| Lot Number | 241387640 |
| Device Expiration Date | 2017-07-25 |
| 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 | 2017-03-07 |