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 2016-03-03 for VIDAS? LYME IGM II 416436 manufactured by Biomerieux Sa.
[39664797]
Biomerieux performed an investigation into the report of a false negative result with the vidas? Lyme igm ii test kit. The customer did not return the sample that was in question; therefore, two(2) negative, three (3) equivocal, and four (4) positive quality control samples were tested on retained samples from the reported lot as well as a second lot. All results from the quality control samples were as expected. Based on the results of the investigation, the vidas? Lyme igm ii test kit is operating as intended within specification. Additionally, the customer's results could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[39664798]
A customer in the united states reported a false negative result while using the vidas? Lyme igm ii. The lyme igm ii was equivocal which was sent out for confirmation. The lyme igm ii then returned a negative result. There were no reports of patient harm.
Patient Sequence No: 1, Text Type: D, B5
[46281336]
A customer in the united states reported false negative results for vidas? Lyme igm ii lot 1004140950. The results of the internal biom? Rieux investigation are as follows: no other complaint related to a false negative result has been registered on the vidas? Lyme igm ii lot 1004140950/160912-0. There is no capa or nonconformity for vidas? Lyme igm ii related to this issue. The analysis of the batch history records - no anomaly related to the control process. Testing included two (2) negative, three (3) equivocal and four (4) positive internal samples on the kit retained lot 1004140950/160912-0 and lot 170321-0. The results obtained for the nine (9) internal samples were found to be within specifications. The analysis of the control card on these nine (9) samples shows that vidas? Lyme igm ii lot 1004140950/160912-0 is in trend with the other batches. Compared to the results obtained during the release, the vidas? Lyme igm ii kit lot 1004140950/160912-0 has not evolved since the release. The vidas? Lyme igm ii package insert indicates 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. In addition, the western blot method is more sensitive than eia technique, which can explain the positivity observed on the western blot versus the vidas? Assays in this case. This case most likely involves early infection and therefore, repeat testing is necessary as directed in the package insert. In conclusion, the kit vidas? Lyme igm ii lot 1004140950/160912-0 is performing within expected specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00043 |
| MDR Report Key | 5477912 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-03-03 |
| Date of Report | 2016-02-05 |
| Date Mfgr Received | 2016-02-05 |
| Device Manufacturer Date | 2015-07-17 |
| Date Added to Maude | 2016-03-03 |
| 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 | MR. RYAN LEMELLE |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318582 |
| 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 | 2016-03-03 |
| Catalog Number | 416436 |
| Lot Number | 1004140950 |
| Device Expiration Date | 2016-09-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-03-03 |