MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-07 for VIDAS? BRAHMS PROCALCITONIN 30450-01 manufactured by Biomerieux Sa.
[136343160]
A customer in the united states contacted biom? Rieux to report the occurrence of a (b)(6) sample out of range (result was 1. 49ng/ml, acceptable range 1. 56 - 2. 30ng/ml) for the vidas brahms procalcitonin (pct) assay. Repeat testing obtained results of 1. 42 and 1. 30 ng/ml. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to the patient's state of health. There was no patient associated with the cap survey sample. Biom? Rieux investigation will be conducted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020790-2019-00008 |
| MDR Report Key | 8317462 |
| Date Received | 2019-02-07 |
| Date of Report | 2019-04-01 |
| Date of Event | 2018-09-03 |
| Date Mfgr Received | 2019-03-06 |
| Device Manufacturer Date | 2018-04-26 |
| Date Added to Maude | 2019-02-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JEFF SCANLAN |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| 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 | 0 |
| Brand Name | VIDAS? BRAHMS PROCALCITONIN |
| Generic Name | VIDAS? BRAHMS PCT |
| Product Code | NTM |
| Date Received | 2019-02-07 |
| Catalog Number | 30450-01 |
| Lot Number | 1006455600 |
| Device Expiration Date | 2019-04-12 |
| 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 | 2019-02-07 |