MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-08 for VIDAS? CMV IGG 30204-01 manufactured by Biomerieux Sa.
[139203336]
A customer in the united states reported a (b)(6) result for a (b)(6) survey sample (survey (b)(6), sample (b)(6)) in association with the vidas? Cmv (cytomegalovirus) igg assay the customer stated they reported that cmv igg antibodies were (b)(6). Their (b)(6) result was 7ua/ml. The expected result was cmv igg antibodies not (b)(6). Biom? Rieux requested the (b)(6) survey report and instructions, and the customer's test reports. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020790-2019-00009 |
| MDR Report Key | 8322645 |
| Date Received | 2019-02-08 |
| Date of Report | 2019-04-17 |
| Date Mfgr Received | 2019-03-19 |
| Device Manufacturer Date | 2018-03-28 |
| Date Added to Maude | 2019-02-08 |
| 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 SA |
| Manufacturer Street | CHEMIN DE L ORME |
| Manufacturer City | MARCY L ETOILE, RHONE 69280, |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VIDAS? CMV IGG |
| Generic Name | VIDAS? CMV IGG |
| Product Code | LFZ |
| Date Received | 2019-02-08 |
| Catalog Number | 30204-01 |
| Lot Number | 1006388970 |
| Device Expiration Date | 2019-02-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280, FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-08 |