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 2017-08-29 for VIDAS? ANALYZER W2205 manufactured by Biomerieux Italia.
[84282896]
A customer in the united states notified biom? Rieux of false negative varicella-zoster virus (vzv) results in association with vidas? Analyzer. The customer tested three samples and received negative results for each one. They retested them in another section of the vidas? Instrument, and two of the samples resulted as positive. Qcv was run twice and failed each time. Customer was asked to perform a retrospective analysis since last correct qcv result. The analysis found three samples, initially resulted as negative, that resulted as positive after retesting. The physician had been notified of the incorrect result, but the patient did not receive the varicella immunoglobulin shot based on the incorrect result. Customer states that wrong results were reported to a physician, but that no incorrect treatment had been given to the patient. Customer states there was no delay in reporting patient results, and there was no patient harm. There is no indication or report from the laboratory that the discrepant results 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 | 3002769706-2017-00260 |
| MDR Report Key | 6828615 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-29 |
| Date of Report | 2017-11-03 |
| Date Mfgr Received | 2017-10-09 |
| Date Added to Maude | 2017-08-29 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | BIOMERIEUX ITALIA |
| Manufacturer Street | VIA DI CAMPOGLIANO 58 PONTE-A EMA |
| Manufacturer City | FIRENZE, ITALY 50015 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 50015 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS? ANALYZER |
| Generic Name | VIDAS? ANALYZER |
| Product Code | GQW |
| Date Received | 2017-08-29 |
| Model Number | W2205 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX ITALIA |
| Manufacturer Address | VIA DI CAMPOGLIANO 58 PONTE-A EMA FIRENZE, ITALY 50015 IT 50015 |
| Brand Name | VIDAS? ANALYZER |
| Generic Name | VIDAS? ANALYZER |
| Product Code | DEW |
| Date Received | 2017-08-29 |
| Model Number | W2205 |
| 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 ITALIA |
| Manufacturer Address | VIA DI CAMPOGLIANO 58 PONTE-A EMA FIRENZE, ITALY 50015 IT 50015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-29 |