MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-31 for VIDAS? B?R?A?H?M?S PCT? 30450-01 manufactured by Biomerieux Sa.
[177267004]
A customer in the united states notified biom? Rieux of falsely underestimated procalcitonin (pct) results in association with the vidas? Brahms procalcitonin 60t (ref 30450-01, lot 1007479440). The results were as follows: pct initial result = 0. 07 ng/ml; pct repeat result = 0. 98 ng/ml. The customer suspected that the initial results were abnormally low, since the patient was being tracked for pct over time. There is no indication or report from the laboratory that the falsely underestimated pct results led to any adverse events 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 | 8020790-2020-00013 |
| MDR Report Key | 9654006 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-31 |
| Date of Report | 2020-03-03 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2019-07-22 |
| Date Added to Maude | 2020-01-31 |
| 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. MATTHEW LOCUS |
| 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 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? B?R?A?H?M?S PCT? |
| Generic Name | VIDAS BRAHMS PROCALCITONIN 60T - 30450-01 |
| Product Code | PRI |
| Date Received | 2020-01-31 |
| Model Number | 30450-01 |
| Catalog Number | 30450-01 |
| Lot Number | 1007479440 |
| 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 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-31 |