VIDAS HCG Adverse Event — Malfunction (MDR 8020790-2020-00041)
VIDAS HCG Adverse Event — Malfunction (MDR 8020790-2020-00041) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: VIDAS HCG; Generic name: VIDAS® HCG; Manufacturer: BIOMERIEUX SA.
| Device | VIDAS HCG |
|---|---|
| Generic name | VIDAS® HCG |
| Manufacturer | BIOMERIEUX SA |
| Report number | 8020790-2020-00041 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | FOREIGN, HEALTH PROFESSIONAL, U |
| Narrative | THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN RUSSIA REGARDING FALSE POSITIVE HCG RESULTS FOR THREE (3) SEPARATE PATIENTS (B, C AND D) IN ASSOCIATION WITH VIDAS® HCG 60 TESTS (REFERENCE (B)(4), LOT 1007502730). A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED WITH THE FOLLOWING RESULTS: CUSTOMER'S MATERIAL. -NO SAMPLE AND NO KIT WERE RECEIVED FOR INVESTIGATION |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →