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 2018-09-12 for VITEK? 2 GN TEST KIT 21341 manufactured by Biomerieux, Inc..
[120737271]
A customer in the united states reported a misidentification of an acinetobacter lwoffii cap survey sample (sputum), as moraxella group in association with the vitek? 2 gn test kit. The customer reported the gn card twice identified moraxella group when the expected result was acinetobacter lwoffii. The customer stated the gram stain gave gram-negative diplocci (gndc) and the oxidase was negative. The customer mentioned that the vitek nh card result was low discrimination moraxella catarrhalis/campylobacter coli. Biom? Rieux advised the customer to use the second survey sample and subculture three times for gn card testing. The results were moraxella group (99% and 97%). The customer stated the isolate is no longer available for evaluation. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00357 |
| MDR Report Key | 7870612 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-12 |
| Date of Report | 2018-10-30 |
| Date Mfgr Received | 2018-10-04 |
| Device Manufacturer Date | 2018-01-02 |
| Date Added to Maude | 2018-09-12 |
| 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 TEST KIT |
| Generic Name | VITEK? 2 GN TEST KIT |
| Product Code | LQM |
| Date Received | 2018-09-12 |
| Catalog Number | 21341 |
| Lot Number | 2410402203 |
| Device Expiration Date | 2019-01-02 |
| 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 | 2018-09-12 |