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 2016-09-19 for VIDAS? MEASLES IGG 30219 manufactured by Biomerieux Sa.
[55103549]
A customer in (b)(6) contacted biom? Rieux to report the occurrence of a false positive result for a neqas survey sample ((b)(6)) in association with the vidas? 3 measles igg assay. The expected result was negative. The vidas raw result was 0. 79, just above equivocal. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health. There was no patient directly associated with the neqas survey sample. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[61018902]
A customer in (b)(6) contacted biom? Rieux to report the occurrence of a false positive result for a (b)(6) in association with the vidas? 3 measles igg assay. An internal biom? Rieux investigation was performed. Specimen (b)(6) measles and mumps igg serology distribution (b)(6) gave an unexpected positive result for some laboratories with vidas? Measles igg. On the (b)(6) report, it is mentioned that : the specimen (b)(6) was expected to be negative for msg (tested negative with siemens enzygnost 1 miu/ml). One hundred thirty six participants, gave the expected result negative. Twenty five participants gave an equivocal result (24 participants using vidas msg). Eighteen participants gave a positive result (15 participants using vidas msg). In pre-distribution testing, the measles igg results were negative with trinity biotech, captia, siemens enzygnost, diasorin liaison assays while it was equivocal with biom? Rieux vidas?. The biom? Rieux lab tested specimen (b)(6) and found an equivocal result with batch 1004566030 / 161110-0 and a positive result with batch 1004457540 / 160929-0. Additional testing was done on four (4) internal sera (2 negative and 2 positive) on the retains kit vidas? Msg 1004457540 / 160929-0 and 1004566030 / 161110-0 : the results did not change in term of serological interpretation since the activity results obtained by the quality control laboratory before batch release. The difference of results inside vidas? Group could be explained by a matrix effect due to this specific specimen. In the package insert, it is mentioned : "interference may be encountered with certain sera containing antibodies directed against reagent components. For this reason, assay results should be interpreted taking into consideration the patient's history. " information from (b)(6) related to the different batches used by the customers during this campaign or regarding specimen (b)(6) and pre-testing results was not received despite several reminders. Without this data, further investigation is not possible. No anomaly involving performances was identified on vidas? Msg assay.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00342 |
| MDR Report Key | 5960978 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-09-19 |
| Date of Report | 2016-08-22 |
| Date Mfgr Received | 2016-08-22 |
| Device Manufacturer Date | 2015-11-26 |
| Date Added to Maude | 2016-09-19 |
| 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? MEASLES IGG |
| Generic Name | VIDAS? MEASLES IGG |
| Product Code | LJB |
| Date Received | 2016-09-19 |
| Catalog Number | 30219 |
| Lot Number | 1004457540 |
| Device Expiration Date | 2016-09-29 |
| 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 | 2016-09-19 |