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 2016-10-04 for VIDAS? MEASLES IGG 30219 manufactured by Biomerieux Sa.
[56352351]
A customer in (b)(6) contacted biomerieux to report the occurrence of discrepant results in association with the vidas measles igg assay as compared to the liason (diasorin) method. The vidas measles igg assay provided a result of equivocal when the diasorin method gave a (b)(6) result. There is no indication or report from the laboratory that the discrepant results led to any adverse event related to any patient's state of health. Culture submittal has been requested by biom? Rieux. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[61650807]
A customer in (b)(6) contacted biom? Rieux to report the occurrence of discrepant results in association with the vidas? Measles igg assay as compared to the liason (diasorin) method. An internal biomereiux investigation was performed. Results are as follows: the customer's sample was not submitted. Since october 2015, there are no other complaints for vidas? Msg batch 1004681180 / 161221-0 and no recurrence on other batches of vidas? Msg for false negative result, false positive result or bad correlation. There is no capa, nor non conformity for a similar issue in relation to the customer's complaint. The analysis of the batch history records showed that seven (7) samples were out of range but these samples were found within their serological interpretation. During the quality control, a specificity and sensibility control were performed: specificity control was performed on 28 negative sera : all sera were found within their specifications. Sensibility control was performed on 54 positive sera : one of them was found negative , it was retested and found positive. The analysis of the control card showed, that vidas? Msg batch 161221-0, was in the trend with the other batches and the results were in their serological interpretation. The quality product laboratory tested three (3) negative and four (4) positive internal msg blood bank samples on the retain kit vidas? Msg batch 1004681180 / 161221-0: the results obtained for these seven (7) samples were in their serological interpretation. However, in the absence of customer's sample, it is impossible to pursue further investigations. The patient serological status has not changed between vidas? And diasorin technique. The performance of vidas? Msg batch 1004681180 / 161221-0 are within the expected specifications indicated by the package insert
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00352 |
| MDR Report Key | 5996109 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-10-04 |
| Date of Report | 2016-08-19 |
| Date Mfgr Received | 2016-08-19 |
| Date Added to Maude | 2016-10-04 |
| 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 | 2016-10-04 |
| Catalog Number | 30219 |
| 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 | 2016-10-04 |