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 2017-06-23 for MINIVIDAS? ANALYZER W1421 manufactured by Biom?rieux Italia.
[78290030]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[78290031]
A customer from the (b)(6) contacted biom? Rieux to report unexpected negative test results for one of the minividas? Test slots. The consistently negative results occurred following preventive maintenance service by a third-party service vendor (aspect scientific). A local biom? Rieux service engineer visited the customer site and identified the rubber seal for the implicated slot was not seated properly preventing proper sample pipetting. Repair was made and the instrument was confirmed operational. Initial retrospective analysis of patient test results associated with the slot indicated that one patient, a pregnant female, was given vzv immunoglobulin unnecessarily due to a false resistant test result. There is no indication or report from the laboratory that the unnecessary vzv immunoglobulin therapy led to any degradation related to the patient's state of health; no further information regarding the patient was provided. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00148 |
| MDR Report Key | 6663697 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-23 |
| Date of Report | 2017-10-11 |
| Date Mfgr Received | 2017-09-15 |
| Date Added to Maude | 2017-06-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | HAZELWOOD 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 | MINIVIDAS? ANALYZER |
| Generic Name | MINIVIDAS? ANALYZER |
| Product Code | LFY |
| Date Received | 2017-06-23 |
| Model Number | W1421 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | MINIVIDAS? ANALYZER |
| Generic Name | MINIVIDAS? ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-23 |
| Model Number | W1421 |
| 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 | 2017-06-23 |