MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 2015-06-25 for VIDAS MEASLES IGG 30219 manufactured by Biomerieux Sa.
[5865051]
On (b)(6) 2015 a customer reported a discrepant result between the vidas measles igg test, ref. (b)(4), and the quest test. The vidas measles igg (msg) assay is intended for use with a vidas (vitek immunodiagnostic assay system) instrument as an automated enzyme-linked fluorescent immunoassay (elfa) for the qualitative detection of igg antibodies to measles (rubeola) virus in human serum. The vidas result was negative with a test value of 0. 46 (<0. 50 negative, > 0. 50 to < 0. 70 equivocal, > 0. 70 positive). The quest result was positive at 2. 09 (<=0. 90 is negative, 0. 91-1. 09 is equivocal, >= 1. 1. Is positive). Based on the discrepancies between the results, the customer delayed the administration of the vaccine. The physician reported a delay in the decision to vaccinate in association with the identified complaint.
Patient Sequence No: 1, Text Type: D, B5
[32712672]
The discrepant result event on the vidas msg kit was investigated. The event resulted from a correlation issue between the vidas kit and the quest technique. The actual sample utilized for the correlation test was not available for return. Internal serum samples (6 positive and 3 negative) were tested on retain samples from lot 1003602810. All samples were found to produce positive and negative results as expected. Based on the results of the investigation, the vidas msg kit remains within the performance claims of the product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00052 |
| MDR Report Key | 4867494 |
| Report Source | 04,05,06 |
| Date Received | 2015-06-25 |
| Date of Report | 2015-06-06 |
| Date of Event | 2015-05-31 |
| Date Mfgr Received | 2015-06-06 |
| Date Added to Maude | 2015-07-22 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 2015-06-25 |
| 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 | 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 | 2015-06-25 |