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 2016-08-30 for VIDAS? LYME IGG 30320 manufactured by Biomerieux Sa.
[53554043]
A customer reported to biomerieux a discrepant result event occurred when using the vidas lyme igg test kit. The customer reported that the vidas lyme igg test kit returned a negative result for a patient sample whereas a western blot on the same sample 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
[58088660]
An investigation into a discrepant result event while using the vidas? Lyme igg test kit was performed. The customer obtained a negative result with the vidas? Lyme igg test kit yet the western blot was positive. An analysis of the batch history records shows no anomaly during the control process. Quality control samples near the cut off of the vidas? Lyme igg test kit were performed on retain samples of the lot in question. All samples returned the expected results. The performance of the lot in question has not changed since original release to the field. Testing of the return patient sample on retain samples from the lot in question as well as another lot was also performed. Both lots returned a negative result consistent with the customer's result. The quality product laboratory has tested the return sample on the retain kit vidas? Lyme igg 1004526300 / 161123-0 and on a other retain kit vidas? Lyme igg 1004350980 / 160914-0. A third technique was utilized in conjunction with the returned patient sample, alldiag optimacheck lyme assay (immunoblot). The customer's return sample was tested and gave negative results for both igg and igm. The negative results obtained with the alldiag optimacheck lyme assay (immunoblot) were in agreement with the vidas? Technique. The most likely root cause is that the euroimmun technique has a higher sensitivity than the alldiag technique and vidas? Lyme igg as tested in our laboratory. Moreover as the patient was treated, the decrease of antibodies with negative igm and a low level of igg shows that the treatment is effective. Based on the results of this investigation, the product is performing in accordance with the limitations of the method.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00160 |
| MDR Report Key | 5914936 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-08-30 |
| Date of Report | 2016-08-05 |
| Date Mfgr Received | 2016-08-05 |
| Date Added to Maude | 2016-08-30 |
| 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 IGG |
| Generic Name | VIDAS? LYME IGG |
| Product Code | LSR |
| Date Received | 2016-08-30 |
| Catalog Number | 30320 |
| Lot Number | 1004526300 |
| Device Expiration Date | 2016-11-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2016-08-30 |