MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-08-08 for VIDAS? ANALYZER W3205 manufactured by Biom?rieux Italia.
[83119295]
A customer from the (b)(6) reported to biom? Rieux a qcv failure in association with the vidas? Analyzer. The customer reported false negative results due to a failed qcv ,at pump r1, 2 & 3 due to the pump not drawing or dispensing liquid. The customer analyzed results obtained after the previous qcv and retested samples. Several false negative results were identified which included tests for cmvg (cytomegalovirus) and ebna (epstein barr nuclear antigen). There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result 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 | 3002769706-2017-00230 |
| MDR Report Key | 6774945 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-08 |
| Date of Report | 2017-12-01 |
| Date Mfgr Received | 2017-11-07 |
| Date Added to Maude | 2017-08-08 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | VIA DI CAMPIGLIANO 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 | LFZ |
| Date Received | 2017-08-08 |
| Model Number | W3205 |
| ID Number | 03573026030292 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX ITALIA |
| Manufacturer Address | VIA DI CAMPIGLIANO 58 PONTE-A EMA FIRENZE, ITALY 50015 IT 50015 |
| Brand Name | VIDAS? ANALYZER |
| Generic Name | VIDAS? ANALYZER |
| Product Code | DEW |
| Date Received | 2017-08-08 |
| Model Number | W3205 |
| ID Number | 03573026030292 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX ITALIA |
| Manufacturer Address | VIA DI CAMPIGLIANO 58 PONTE-A EMA FIRENZE, ITALY 50015 IT 50015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-08 |