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 2018-09-24 for VITEK? 2 GN ID TEST KIT 21341 manufactured by Biomerieux, Inc..
[121570177]
A customer in the united states reported a misidentification of shigella boydii as escherchia coli in association with the vitek? 2 gn id test kit. The customer reported that a clinical isolate was strictly for research use, and was from a clinical specimen in 2014. The customer stated that they tested the clinical isolate, qc isolate atcc 35965 (shigella boydii), and two other isolates (shigella strains cdph07 and cdph15) from a state reference lab. All isolates had the same escherchia coli identification. The customer reported that they grew the organism in tsb (trypcase soy broth) , or bhi (brain heart infusion) then streaked only once to the tsa (trypcase soy agar) before testing the isolate with the gn id card. Biom? Rieux requested that the customer perform retesting of the organism after performing two subcultures on a tsa or tsab (tryptic soy agar + sheep blood). There was no patient involvement as the event pertained to a clinical research study. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00387 |
| MDR Report Key | 7901911 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-24 |
| Date of Report | 2018-12-04 |
| Date Mfgr Received | 2018-11-07 |
| Device Manufacturer Date | 2018-03-15 |
| Date Added to Maude | 2018-09-24 |
| 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 | MS. DEBRA BROYLES |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX, INC. |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD 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 ID TEST KIT |
| Generic Name | VITEK? 2 GN ID TEST KIT |
| Product Code | LQM |
| Date Received | 2018-09-24 |
| Catalog Number | 21341 |
| Lot Number | 2410474403 |
| Device Expiration Date | 2019-03-15 |
| 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 HAZELWOOD MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-24 |