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 2018-07-06 for VIDAS? CMV IGM 30205-01 manufactured by Biomerieux Sa.
[113339861]
A customer in the (b)(6) contacted biom? Rieux to report the occurrence of a false negative result for a neqas survey sample (distribution (b)(4) sample (b)(6)) in association with the vidas? Cmv igm assay. The vidas? Cmv igm assay lot number was not provided by the customer. The customer stated the neqas sample was not graded due to difficulty obtaining the expected result by most survey participants. The sample is no longer available at the customer site. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to any patient's state of health. There was no patient directly associated with the survey sample. Although product reference 30205 is not sold/distributed in the united states, a similar product is (reference 30205-01). Biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00097 |
| MDR Report Key | 7666114 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-06 |
| Date of Report | 2018-09-11 |
| Date Mfgr Received | 2018-08-14 |
| Date Added to Maude | 2018-07-06 |
| 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 | MR. JEFF SCANLAN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318694 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | CHEMIN DE L ORME 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 IGM |
| Generic Name | VIDAS? CMV IGM |
| Product Code | LKQ |
| Date Received | 2018-07-06 |
| Model Number | 30205-01 |
| 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 | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-06 |