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 2016-09-28 for VIDAS? LYME IGM II 416436 manufactured by Biomerieux Sa.
[55871735]
Patient Sequence No: 1, Text Type: N, H10
[55871736]
A customer reported to biomerieux a discrepant result event occurred when using the vidas lyme igm test kit. The customer reported that the vidas lyme igm returned a negative result; however, confirmatory testing by western blot returned a positive result. When specifically asked, the customer indicated no adverse impact to the patient or delay in results was experienced as a result of this event. An investigation has been initiated by biomerieux to investigate this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2016-00348 |
| MDR Report Key | 5984256 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-09-28 |
| Date of Report | 2016-08-29 |
| Date Mfgr Received | 2016-08-29 |
| Date Added to Maude | 2016-09-28 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | CHEMIN DE L ORME |
| Manufacturer City | MARCY L ETOILE, RHONE 69280 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS? LYME IGM II |
| Generic Name | VIDAS? LYME IGM II |
| Product Code | LSR |
| Date Received | 2016-09-28 |
| Catalog Number | 416436 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-28 |