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 2017-01-05 for VIDAS? LYME IGM II 416436 manufactured by Biomerieux Sa.
[64019833]
A customer in the united states reported to biom? Rieux a false negative result for six (6) samples in association with vidas? Lyme igm ii test kit. The vidas? Lyme igm test result was negative for all 6 samples, although 2 were known by the customer to be positive. All samples were positive by western blot, and the bands present for the 2 known positives were band 23 (osp c) and band 41. 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. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[68497836]
A biom? Rieux investigation was conducted. A review of quality records for vidas? Lyme igm ii lot 1004988230 confirmed the lot met the manufacturing criteria and there were no similar issues. Five (5) reserve samples were tested from the lot. (target: vt : 1. 22, 0. 22 , 2. 42, 0. 01, and 0. 01) all test results for each sample were within the expected specifications. According to the wb package insert (viramed biotech ag - borrelia b31 igm virastripe? ), it used the strain borrelia burgdorferi sensu stricto (american strain borrelia). The vidas? Lyme igm ii used recombinant antigens from borrelia burgdorferi sensu stricto, b afzelii and b garinii. The vidas? Lyme igm ii package insert states: "limitations of the method": a negative result in the vidas? Lyme igm ii assay does not rule out the possibility of b. Burgdorferi infection in a patient. Patients in early stages of infection or who have undergone antibiotic therapy, may not produce measurable antibodies. Patients with clinical history and/or symptoms suggestive of lyme disease, but with negative test results, should be reported as "no detectable antibodies to b. Burgdorferi". A second specimen should be collected in 4-6 weeks. Note: it is estimated that in 50% of subjects, in the primary stage of disease, antibody levels in blood remain below the detectable threshold (10). Further investigation is not possible without the customer isolate. The vidas? Lyme igm ii lot 1004988230 performed within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2017-00001 |
| MDR Report Key | 6226239 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-01-05 |
| Date of Report | 2017-02-15 |
| Date Mfgr Received | 2017-01-20 |
| Date Added to Maude | 2017-01-05 |
| 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 | ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS 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 | LYR |
| Date Received | 2017-01-05 |
| Catalog Number | 416436 |
| Lot Number | 1004988230 |
| Device Expiration Date | 2017-09-15 |
| 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 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-05 |