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 2018-08-14 for VIDAS? CMV IGM 30205 manufactured by Biomerieux Sa.
[117442413]
A customer from (b)(6) reported false negative results in association with the vidas? Cmv (cytomegalovirus) igm (lot 1006247630). The customer reported they tested three samples from one patient with (b)(6), and received (b)(6) results with the vidas cmv igm assay while other methods (cobass 6000, elisa diapro, pcr) were positive. Sample 1 was tested with cmv igm on elisa and a positive result was sent to physician, and the pcr result was positive. Sample 2 was tested with cmv igm on vidas and a negative result was sent to physician, and the pcr result was positive. Sample 3 was tested again on elisa, vidas and another automated immunology system. Results were positive with elisa and the immunology system, and negative with vidas. The customer stated a wrong result was reported to a physician, but the patient was not harmed or treated incorrectly, as the physician noticed the different test results immediately. The customer stated there was a delay in reporting results which took twice as long as the first test. 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 | 3002769706-2018-00147 |
| MDR Report Key | 7782870 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-14 |
| Date of Report | 2018-10-03 |
| Date Mfgr Received | 2018-09-06 |
| Device Manufacturer Date | 2018-02-09 |
| Date Added to Maude | 2018-08-14 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. DEBRA BROYLES |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318805 |
| 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 | 2018-08-14 |
| Catalog Number | 30205 |
| Lot Number | 1006247630 |
| Device Expiration Date | 2018-12-07 |
| 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 | 2018-08-14 |