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 2018-04-26 for VIDAS? CA 15-3 ASSAY 30429 manufactured by Biomerieux Sa.
[106742850]
A customer in (b)(6) reported discrepant results for a patient's samples in association with the vidas? Ca 15-3 assay. The (b)(6) 2018 results: vidas first test: 372. 36 iu/ml, vidas second test: 764. 07 iu/ml, roche test: 975ku/l. The (b)(6) 2018 results: vidas first test: 506. 87 iu/ml, vidas second test: 528. 09 iu/ml, roche test: 721ku/l. The customer stated the incorrect (b)(6) 2018 result was reported to the clinician, and that the result affected patient treatment. The customer stated there was discussion to switch the patient therapy , but the customer indicated that they think the therapy has not yet been switched. 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 | 3002769706-2018-00060 |
| MDR Report Key | 7465282 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-04-26 |
| Date of Report | 2018-07-11 |
| Date of Event | 2018-02-23 |
| Date Mfgr Received | 2018-06-15 |
| Date Added to Maude | 2018-04-26 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM RD |
| 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 | 3 |
| Brand Name | VIDAS? CA 15-3 ASSAY |
| Generic Name | VIDAS? CA 15-3 ASSAY |
| Product Code | LTK |
| Date Received | 2018-04-26 |
| Catalog Number | 30429 |
| Lot Number | 1006022590 |
| Device Expiration Date | 2018-09-30 |
| 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, 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-26 |