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 2015-12-11 for VIDAS ? MEASLES IGG 30219 manufactured by Biomerieux Sa.
[33303532]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[33303533]
On (b)(6) 2015 a customer reported two false negative results when using vidas measles igg test. The customer ran 14 study samples that were also tested using chemiluminescence. Two sample results came back as negative however, both samples were positive when retested using the clia methodology. Both samples were sent to an outside lab for confirmation with liason xl utilizing a chemiluminescence method immunoassay (clia) technology. Both sample results were positive. Samples were for a comparison study and did not involve providing results to physicians.
Patient Sequence No: 1, Text Type: D, B5
[87005813]
A customer reported two (2) false negative results when using vidas? Measles igg test. An internal biom? Rieux investigation was performed. Tests performed did not fully reproduce the customer issue with the return sample on the retained kit of vidas? Measles igg lot 1003602810. Indeed, the assay performed gave an equivocal result with a test value to 0. 53. This returned sample was also tested on two (2) other lots of vidas? Measles igg and gave a negative result (test value at 0. 46) on one (1) lot and equivocal (test value at 0. 50) result for the other lot. The returned sample was tested on a competitor kit (clintech microimmune measle mevg 011) and it gave a positive result. In conclusion, tests did not fully reproduce the customer issue and as the package insert claims a relative sensitivity at 96. 9% with a confidence interval at 93. 4% - 98. 6%, it was assessed that the lot 1003602810 of vidas? Measles igg is compliant to its claimed performance. The batch history record did not show any anomaly during the control batch. For all samples tested: (22 positives samples and 5 negatives samples) the results were consistent and the status of them were conform.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00166 |
| MDR Report Key | 5290037 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-12-11 |
| Date of Report | 2017-06-13 |
| Date Mfgr Received | 2015-12-04 |
| Device Manufacturer Date | 2014-12-09 |
| Date Added to Maude | 2015-12-11 |
| 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 ? MEASLES IGG |
| Generic Name | VIDAS ? MEASLES IGG |
| Product Code | LJB |
| Date Received | 2015-12-11 |
| Catalog Number | 30219 |
| Lot Number | 1003602810 |
| Device Expiration Date | 2015-10-14 |
| 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 | 2015-12-11 |