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 2017-06-20 for VIDAS? LYME IGM 30319 manufactured by Biomerieux Sa.
[78139623]
Biom? Rieux conducted an internal investigation: the analysis of the batch history records showed no anomaly during the manufacturing and control process. The analysis of the control card of vidas? Lyme igm lot 1005181000/170906-0 on five (5) internal samples showed that there was no significant variation for this lot compared to the other lots. Biom? Rieux has not observed any significant evolution of the vidas lyme igm lot 1005181000/170906-0 since its release. On january 20th and june 8th, the product quality laboratory tested five (5) internal samples on the retain kit vidas? Lyme igm lot 1005181000/170906-0 on vidas? Pc, the results obtained are similar to the results obtained during the release of the batch. Biom? Rieux has not any significant evolution of the vidas lyme igm lot 1005181000/170906-0 since its release. However, the customer did not provide biom? Rieux with any information (sample composition, clinical history, stage of infection, etc. ) on the patient samples except for the age and sex. Without the returned sample and patient information, biom? Rieux cannot pursue the investigations and explain these results. Only the result of the western blot test could determine the serological state of these samples. Additionally, biom? Rieux advised the customer to enroll in external quality assessment (eqa) programs such as, prospective biology / ctcb, which are specialized and accredited institutions for this type of testing. The tests sent are common to several dozen participants and the composition of the tests is known (pool of manufactured sera). The performance of vidas? Lyme igm lot 1005181000/170906-0 are within expected specifications. In the package insert, it is also written in the section -limitations of the method: antibody detection methods do not provide definitive results for establishing or ruling out diagnosis of lyme borreliosis. Negative results with the vidas? Lyme igm and vidas lyme igg assays does not rule out the possibility of b. Burgdorferi infection in a patient. Patients in the early stages of infection or who have undergone antibiotic therapy, may not produce measurable igm and igg. Patients with clinical history and/or symptoms suggestive of lyme borreliosis, but with negative test results, should be reported as "no detectable antibodies to b. Burgdorferi". A second specimen should be collected 4-6 weeks later. Note: it is estimated that in 50% of subjects in the primary stage of disease, antibody levels remain below the detectable threshold. Clinical symptoms, epidemiological information and other laboratory test results must all be considered when interpreting vidas lyme igm and igg assay results.
Patient Sequence No: 1, Text Type: N, H10
[78139624]
A customer in (b)(6) reported to biom? Rieux that they observed a false negative result as part of an eeq when using the product: vidas? Lyme igm (ref. 30319) - lot 1005181000. The customer performed tests as part of a biomnis eeq on lyme igm (the reference of the eeq is not yet known). Out of the 13 samples tested as part of this eeq, 11 results were reported to be negative and the expected result was positive.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00140 |
| MDR Report Key | 6653727 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-20 |
| Date of Report | 2017-06-20 |
| Date Mfgr Received | 2017-05-22 |
| Device Manufacturer Date | 2016-09-26 |
| Date Added to Maude | 2017-06-20 |
| 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 | SAINT 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 | 2017-06-20 |
| Model Number | 30319 |
| Lot Number | 1005181000 |
| Device Expiration Date | 2017-09-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-06-20 |