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 2017-02-23 for VIDAS? ANALYZER 99735 manufactured by Biom?rieux Sa.
[68356751]
A customer in the united stated contacted biom? Rieux to report a qcv (quality control verification) failure (position e1) in association with the vidas? Analyzer. As the same discrepancy could have occurred with a patient sample since the last successful qcv ((b)(6) 2016), the customer was instructed to conduct a retrospective analysis. At this time it is unknown if this failure impacted patient results. There is no indication or report from the laboratory that the failed qcv identified any adverse event related to any patient's state of health. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[69121971]
Follow-up medwatch is being sent to correct the date received by manufacturer to 07feb2017, when data supporting the malfunction event was reported by the customer. Retrospective data was submitted on 07feb2017. According to the results of the controls performed on position e1, patient results could be impacted if they were tested during the period between the (b)(6) 2017. However, the customer indicated not being able to rerun all of the samples and only able to rerun/repeat the last samples (5 or 6 samples) as these samples were still in the laboratory. Therefore, without rerunning potentially affected samples, potential impact can't be estimated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2017-00035 |
| MDR Report Key | 6353461 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-23 |
| Date of Report | 2017-07-12 |
| Date Mfgr Received | 2017-06-14 |
| Date Added to Maude | 2017-02-23 |
| 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 | BIOM |
| Manufacturer Street | CHEMIN DE L ORME 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? ANALYZER |
| Generic Name | VIDAS? ANALYZER |
| Product Code | DEW |
| Date Received | 2017-02-23 |
| Model Number | 99735 |
| Lot Number | IVD3004901 |
| ID Number | 03573026140427 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX SA |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-23 |