VITEK® 2 GP ID TEST KIT Adverse Event — Malfunction (MDR 1950204-2020-00128)
VITEK® 2 GP ID TEST KIT Adverse Event — Malfunction (MDR 1950204-2020-00128) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: VITEK® 2 GP ID TEST KIT; Generic name: VITEK® 2 GP ID TEST KIT; Manufacturer: BIOMERIEUX, INC..
| Device | VITEK® 2 GP ID TEST KIT |
|---|---|
| Generic name | VITEK® 2 GP ID TEST KIT |
| Manufacturer | BIOMERIEUX, INC. |
| Report number | 1950204-2020-00128 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | FOREIGN, HEALTH PROFESSIONAL, U |
| Narrative | A CUSTOMER IN (B)(6) NOTIFIED BIOM¿RIEUX OF A MISIDENTIFICATION OF STAPHYLOCOCCUS HAEMOLYTICUS AS STAPHYLOCOCCUS LENTUS IN ASSOCIATION WITH THE VITEK¿ 2 GRAM POSITIVE (GP) IDENTIFICATION (ID) TEST KIT (REF. 21342, LOT 2421287103). IN RESPONSE TO THE CUSTOMER COMPLAINT, A BIOM¿RIEUX FIELD APPLICATION SPECIALIST (FAS) VISITED THE CUSTOMER SITE AND CONFIRMED THE FOLLOWING: RECOMMENDATIONS FOR ISOLATE |
| Source | openFDA MAUDE (device adverse events) |
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