MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-24 for VIDAS? CMV IGM 30205 manufactured by Biomerieux Sa.
[134092855]
A customer from (b)(6) notified biom? Rieux of obtaining a false negative result when testing a neqas quality control sample with vidas? Cmv igm. The expected value of the sample number (b)(6) was positive, but the customer obtained a negative value (0. 69 tv). As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020790-2019-00005 |
| MDR Report Key | 8275491 |
| Date Received | 2019-01-24 |
| Date of Report | 2019-03-14 |
| Date Mfgr Received | 2019-02-17 |
| Device Manufacturer Date | 2018-04-27 |
| Date Added to Maude | 2019-01-24 |
| 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. CANDACE MARTIN |
| 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 | 0 |
| Brand Name | VIDAS? CMV IGM |
| Generic Name | VIDAS? CMV IGM |
| Product Code | LKQ |
| Date Received | 2019-01-24 |
| Catalog Number | 30205 |
| Lot Number | 1006463790 |
| Device Expiration Date | 2019-03-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-01-24 |