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 manufactured by Biomerieux Sa.
[113339898]
A customer from (b)(6) notified biom? Rieux of obtaining equivocal and false negative results when testing their internal quality control (iqc) virotrol? Torch-m sample with a new batch of vidas? Cmv igm, lot 1005897340. In spite of the discrepant results, the new batch was implemented 21-oct-2017. The iqc functioned as intended by sending a warning to the customer. The customer checked the results and found no impact to patient samples. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health. There was no patient associated with this discrepant quality control result. Although product reference 30205 is not sold/distributed in the united states, a similar product is (reference 30205-01). A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00098 |
| MDR Report Key | 7666722 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-06 |
| Date of Report | 2018-09-19 |
| Date Mfgr Received | 2018-08-24 |
| Device Manufacturer Date | 2017-08-11 |
| 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 | MRS. CANDACE MARTIN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | 376 CHEMIN DE L ORME |
| Manufacturer City | MARCY L ETOILE, RHONE 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 | 2018-07-06 |
| Model Number | 30205 |
| Device Expiration Date | 2018-06-21 |
| 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 | 2018-07-06 |