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 2019-02-19 for VIDAS? CMV IGG 30204-01 manufactured by Biomerieux Sa.
[140158294]
A customer in the united states reported a (b)(6) result for a (b)(6) survey 2018 (b)(6) sample (b)(6) in association with the vidas? Cmv igg assay. The customer twice obtained a (b)(6) result, when the expected result was (b)(6). There was no patient involvement. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020790-2019-00014 |
| MDR Report Key | 8350673 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-02-19 |
| Date of Report | 2019-04-17 |
| Date Mfgr Received | 2019-03-19 |
| Device Manufacturer Date | 2018-03-28 |
| Date Added to Maude | 2019-02-19 |
| 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 | 3 |
| Brand Name | VIDAS? CMV IGG |
| Generic Name | VIDAS? CMV IGG |
| Product Code | LFZ |
| Date Received | 2019-02-19 |
| 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 | 2019-02-19 |