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 2019-01-24 for VIDAS? TPSA 30428 manufactured by Biomerieux Sa.
[135540435]
A customer in (b)(6) reported a falsely over-estimated result when testing three patient samples in association with vidas? Tpsa (total prostate specific antigen) lot# 1006670400. The initial test results were reported to the clinician and did not match the clinical status of the patients, so retesting was requested. It was reported that repeat tests were performed in the same day but not in the same time and section of the instrument. It was noted that these tests were performed after expiration date of calibration. The last calibration was performed on (b)(6) 2018 and was conforming on (b)(6) 2018. The internal quality control c1 was conforming. The customer tested also new samples from the patients. Patient 1 : first test :30. 04 ng/ml. Second test: :0. 49 ng/ml. New sample : 0. 6 ng/ml. Patient 2: first test :0. 61 ng/ml. Second test: :4. 63 ng/ml. New sample : 4. 78 ng/ml. Patient 3: first test :0. 56 ng/ml. Second test: : n/a - lack of sample. New sample : 22. 31 ng/ml. 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 | 8020790-2019-00002 |
| MDR Report Key | 8273896 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-01-24 |
| Date of Report | 2019-03-07 |
| Date Mfgr Received | 2019-02-05 |
| Device Manufacturer Date | 2018-07-27 |
| Date Added to Maude | 2019-01-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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. 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? TPSA |
| Generic Name | VIDAS? TPSA |
| Product Code | LTJ |
| Date Received | 2019-01-24 |
| Catalog Number | 30428 |
| Lot Number | 1006670400 |
| 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 | 2019-01-24 |