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 2018-10-29 for VIDAS? TSH 30400 manufactured by Biomerieux Sa.
[126520877]
A customer in (b)(6) reported a false low result for one healthy patient during a control exam, with two different lots of the vidas? Tsh assay. The customer stated the tsh result from lot 1006127340 was <0. 05. The result was reported to the endocrinologist, and they did not agree with the result, so the patient was sent to another lab for repeat analysis. The repeat result was within normal values. The customer then obtained another sample from the patient and repeated the tsh assay with lot 1006277930, and the result was <0. 05. The customer reported that the patient's t4 and total t4 values were normal. The customer stated that patient treatment was not impacted and there was no delay. 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 | 3002769706-2018-00226 |
| MDR Report Key | 8017067 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-10-29 |
| Date of Report | 2018-12-27 |
| Date Mfgr Received | 2018-11-30 |
| Device Manufacturer Date | 2018-02-13 |
| Date Added to Maude | 2018-10-29 |
| 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 | MS. DEBRA BROYLES |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | CHEMIN DE L ORME |
| Manufacturer City | MARCY L ETOILE, RHONE 69280, |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS? TSH |
| Generic Name | VIDAS? TSH |
| Product Code | KLI |
| Date Received | 2018-10-29 |
| Catalog Number | 30400 |
| Lot Number | 1006277930 |
| Device Expiration Date | 2019-01-29 |
| 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 | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280, FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-29 |