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 2017-12-01 for VIDAS? LYME IGG 30320 manufactured by Biomerieux, Sa.
[94380278]
A customer in (b)(6) reported to biom? Rieux that they have observed false negative results when using the products vidas? Lyme igm (ref. 30319) lot 1005810050 and vidas? Lyme igg (ref. 30320) lot 1005816250. The patient is a (b)(6) -year-old male with complaints of joint pain. The patient did not remember having a tick bite and erythema migrans was not observed. On (b)(6) 2017, the customer tested the patient's sample on both vidas? Lyme igm and vidas? Lyme igg. The results obtained were negative with the following values:? Lyme igg: 0. 10. ? Lyme igm: 0. 02. The patient's sample had been tested with western blot technique (borrelia euroline-wb igg). The results were positive with 3 bands for igm and 4 bands for igg. The customer reported that patient results were affected and wrong results were reported to a physician. The customer stated there was no delay in reporting results. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health. A biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00389 |
| MDR Report Key | 7074786 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-01 |
| Date of Report | 2018-01-31 |
| Date Mfgr Received | 2018-01-04 |
| Device Manufacturer Date | 2017-07-04 |
| Date Added to Maude | 2017-12-01 |
| 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 | 376 CHEMIN DE L'ORME |
| Manufacturer City | MARCY L'ETOILE, 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 IGG |
| Generic Name | VIDAS? LYME IGG |
| Product Code | LSR |
| Date Received | 2017-12-01 |
| Catalog Number | 30320 |
| Lot Number | 1005816250 |
| Device Expiration Date | 2018-06-22 |
| 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 | 376 CHEMIN DE L'ORME MARCY L'ETOILE, 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-01 |