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 2018-03-08 for VIDAS? CA 15-3 ASSAY 30429-01 manufactured by Biomerieux, Sa.
[101864234]
A customer in (b)(6) contacted biom? Rieux to report a falsely overestimated (609. 55 iu/ml) result in association with the vidas? Ca 15-3 assay. The customer stated the patient was prescribed inappropriate treatment (faslodex? /palbociclib) based on the discrepant vidas result. A second patient sample was tested 10 days later, and the result was much lower at 314. 28 iu/ml. Because of this, the initial sample was retested and provided a result of 277. 19 iu/ml (instead of the initial result of 609. 55 iu/ml). Review of this patient's vidas? Ca 15-3 test history indicated: (b)(6) 2017, 163. 89. (b)(6) 2017, 146. 99. (b)(6) 2017, 207. 26. (b)(6) 2017, 249. 12. (b)(6) 2017, 295. 29. (b)(6) 2018, 340. 01. (b)(6) 2018, 383. 41. (b)(6) 2018, 609. 55. (b)(6) 2018, 314. 28. Only the result on (b)(6) 2018 was elevated. The instructions for use (ifu) indicate that "samples with ca 15-3 titers >400 u/ml should be re-assayed after maximum dilution by 1/10 in ca 15-3 diluent. " there is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse impact related to the patient's state of health. Although vidas ca 15-3 assay (ref. 30429) is not sold or marketed in the united states, a similar product (ref. 30429-01) is sold in the united states. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00030 |
| MDR Report Key | 7323327 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-08 |
| Date of Report | 2018-07-11 |
| Date of Event | 2018-02-16 |
| Date Mfgr Received | 2018-06-15 |
| Device Manufacturer Date | 2017-10-13 |
| Date Added to Maude | 2018-03-08 |
| 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 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, 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 | 2018-03-08 |
| Model Number | 30429-01 |
| 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 | 1. Other | 2018-03-08 |