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 2018-07-09 for VIDAS? CMV IGM 30205 manufactured by Biomerieux Sa.
[113515857]
On (b)(6) 2018, a customer from (b)(6) notified biom? Rieux of a false negative result when testing with vidas? Cmv igm (ref 30205, lot 1005897340). The customer had retested three patient samples with new batches of cmv igm. For one of the patient samples, the result with the new batches obtained positive results (1. 06-1. 22). This patient sample had tested negative with the impacted lot on (b)(6) 2017. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health. 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 | 3002769706-2018-00103 |
| MDR Report Key | 7669492 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-09 |
| Date of Report | 2018-08-23 |
| Date of Event | 2017-11-21 |
| Date Mfgr Received | 2018-07-26 |
| Device Manufacturer Date | 2017-08-11 |
| Date Added to Maude | 2018-07-09 |
| 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 | 2018-07-09 |
| Model Number | 30205 |
| Lot Number | 1005897340 |
| 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 | 2018-07-09 |