MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-03-11 for VIDAS? CMV IGM 30205 manufactured by Biomerieux Sa.
[142373944]
A customer in (b)(6) reported (b)(6) results in association with the vidas? Cmv igm assay (lot 1006946280). The customer reported that they ran a virotrol sample with lot 1006946280, and results were between (b)(6), with an interpretation of (b)(6) to equivocal. The customer stated the previous lot obtained between (b)(6), with a (b)(6)interpretation. No other information was provided by the customer. No patient information was provided by the customer. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020790-2019-00017 |
| MDR Report Key | 8409560 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-03-11 |
| Date of Report | 2019-06-25 |
| Date Mfgr Received | 2019-05-27 |
| Device Manufacturer Date | 2018-12-13 |
| Date Added to Maude | 2019-03-11 |
| 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 | 376 CHEMIN DE L ORME |
| Manufacturer City | MARCY L ETOILE, 69280 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS? CMV IGM |
| Generic Name | VIDAS? CMV IGM |
| Product Code | LKQ |
| Date Received | 2019-03-11 |
| Catalog Number | 30205 |
| Lot Number | 1006946280 |
| 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 | 376 CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-11 |