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 2016-07-06 for VIDAS? MEASLES IGG 30219 manufactured by Biomerieux Sa.
[48925684]
A customer in the (b)(6) notified biom? Rieux of a false positive result with the vidas? Measles igg (reference (b)(4)); a single specimen (specimen (b)(4)) was tested during (b)(6) qc. In pre-distribution testing the measles igg results were negative with trinity biotech, captia, siemens enzygnost, diasorin liaison assays and equivocal with biom? Rieux vidas?. Based on the information provided there was no adverse events, negative patient impact or delay in results.
Patient Sequence No: 1, Text Type: D, B5
[55591033]
This report was initially submitted following notification that a customer in the (b)(6) reported an occurrence of a false positive result for (b)(6) specimen (b)(6) in association with the vidas measles igg assay. The expected result was "negative". Biom? Rieux investigation was conducted. The (b)(6) (distribution (b)(6)) report indicates: one-hundred thirty-six (136) participants gave the correct answer negative. Twenty-five (25) participants gave an equivocal answer (24 participants using vidas msg). Eighteen (18) participants gave a positive answer (15 participants using vidas msg). In pre-distribution testing, the measles igg results were negative with trinity biotech, captia, siemens enzygnost, diasorin liaison assays and equivocal with biom? Rieux vidas. Review of complaint history indicates that no other complaint has been registered for vidas msg lot 1004457540 / 160929-0 for external control from (b)(6). Analysis of the manufacturing batch history records showed no anomaly during the control process. The analysis of the control charts for five (5) internal (b)(6) (three negative and two positive) on six (6) vidas? Msg batches showed that all results are in the trend and within specifications or acceptable without change of interpretation. The quality product laboratory tested internal (b)(6) on the retain kit vidas msg 1004457540 / 160929-0; the results were compliant with specifications. There is no evidence to suggest the performance of vidas msg lot 1004457540 / 160929-0 is outside specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00115 |
| MDR Report Key | 5772824 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-07-06 |
| Date of Report | 2016-07-01 |
| Date Mfgr Received | 2016-07-01 |
| Date Added to Maude | 2016-07-06 |
| 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. JONATHAN NONNEMACHER |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer Phone | 9196203396 |
| 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 | 2016-07-06 |
| Catalog Number | 30219 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-07-06 |