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 2017-12-05 for VIDAS? LYME IGM 30319 manufactured by Biomerieux Sa.
[93735482]
A customer in the (b)(6) notified biom? Rieux of discrepant results associated with vidas? Lyme igm (reference 30319). The customer reported having a recent patient sample that flagged igg positive and igm negative on the initial screening with vidas?. The sample was sent to a reference laboratory and the result was positive for both igg and igm. The reference laboratory borrelia igm lineblot indicated antibody to osp17 antigen to be detected. Patient treatment was delayed resulting in further issues. A biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00392 |
| MDR Report Key | 7083102 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-05 |
| Date of Report | 2018-02-16 |
| Date Mfgr Received | 2018-01-23 |
| Device Manufacturer Date | 2017-01-27 |
| Date Added to Maude | 2017-12-05 |
| 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 | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX 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? LYME IGM |
| Generic Name | VIDAS? LYME IGM |
| Product Code | LSR |
| Date Received | 2017-12-05 |
| Catalog Number | 30319 |
| Lot Number | 1005460450 |
| Device Expiration Date | 2017-12-12 |
| 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 | 1. Required No Informationntervention | 2017-12-05 |