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 2018-08-28 for VITEK? 2 GRAM NEGATIVE ID TEST KIT 21341 manufactured by Biomerieux Inc..
[119157072]
A customer in the united states contacted biom? Rieux to report a misidentification of escherichia coli as shigella sonnei for a urine isolate in association with the vitek? 2 gram negative (gn) identification (id) test kit. The isolate was a lactose fermenter, indicating an identification of shigella was not possible. Repeat test via different gn id lot number gave an organism identification of escherichia coli. No information was provided by the customer regarding any reference or alternate method testing performed. The customer stated they "bench id'd" the organism. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to the patient's state of health. Biom? Rieux requested strain submittal from the customer. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00305 |
| MDR Report Key | 7822409 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-28 |
| Date of Report | 2018-10-22 |
| Date Mfgr Received | 2018-09-25 |
| Device Manufacturer Date | 2018-02-14 |
| Date Added to Maude | 2018-08-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JEFF SCANLAN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAXELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318805 |
| 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 GRAM NEGATIVE ID TEST KIT |
| Generic Name | VITEK? 2 GN ID TEST KIT |
| Product Code | LQM |
| Date Received | 2018-08-28 |
| Catalog Number | 21341 |
| Lot Number | 2410445403 |
| Device Expiration Date | 2019-02-14 |
| 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 | 2018-08-28 |