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 2017-04-28 for VIDAS? ANALYZER W2205 manufactured by Biomerieux Sa.
[74153233]
A customer in the us reported to biom? Rieux discrepant results associated with vidas? Analyzer (reference w2205). The customer reported qcv failure with the vidas? Analyzer. Biom? Rieux instructed the customer to rerun the qcv check and report back with the results. The customer reported a subsequent qcv failure. Biom? Rieux requested a retrospective data analysis be completed since the last passing qcv. The customer reported back with the data analysis results. One (1) patient was affected by the qcv failure. An initial negative mumps result was retested to be positive. The incorrect result was reported to the physician; however, the customer indicated the patient did not experience any adverse events. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[74825647]
The adverse event box was inadvertently checked. This report is to correct the type of report as a product problem report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2017-00081 |
| MDR Report Key | 6529191 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-28 |
| Date of Report | 2017-08-17 |
| Date of Event | 2017-04-28 |
| Date Mfgr Received | 2017-07-25 |
| Date Added to Maude | 2017-04-28 |
| 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?RIEUX SA |
| 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 | 2017-04-28 |
| Model Number | W2205 |
| Lot Number | DASA2374 |
| 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 | 2017-04-28 |