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 2016-02-24 for VIDAS? MUMPS IGG 30218 manufactured by Biomerieux Sa.
[39001299]
A customer in unites states reported a false negative result while using; vidas mumps igg.
Patient Sequence No: 1, Text Type: D, B5
[46480827]
A customer in united states reported discrepant results between vidas? Mumps igg (ref 30218) lot 1004183650/160602-0 and another method (quest). Results of the biom? Rieux internal investigation are as follows: no other complaint related to bad correlation has been registered on the vidas? Igg lot 1004183650/160602-0. There is no nonconformity linked to the customer's anomaly. The analysis of the batch history records shows no anomaly during the control process. Four (4) internal samples were tested (retained vidas? Igg lot 160602-0 and retained vidas? Igg lot 161218-0). Results for all four (4) internal samples were within specifications. The analysis of the control cards for the four (4) internal samples shows that the vidas? Igg lot 1004183650/160602-0 is in the trend of the other batches. The customer's sample was tested on the retained vidas? Igg lot 160602-0 and on the retained vidas? Igg lot 161218-0. The results obtained (low equivocal) were the same as the customer's results (low equivocal and high negative); however, vidas? Mumps igg performance does not claim 100% in terms of specificity or sensitivity. Without the quest performance data (specificity/sensitivity) and the lack of a third test method, it is therefore not possible to determine which result is correct. In conclusion, a product problem was not identified for vidas? Mumps igg lot 1004183650/160602-0.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00039 |
| MDR Report Key | 5458127 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-02-24 |
| Date of Report | 2016-02-08 |
| Date Mfgr Received | 2016-02-08 |
| Date Added to Maude | 2016-02-24 |
| 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? MUMPS IGG |
| Generic Name | VIDAS? MUMPS IGG |
| Product Code | LJY |
| Date Received | 2016-02-24 |
| Catalog Number | 30218 |
| Lot Number | 1004183650 |
| Device Expiration Date | 2016-06-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2016-02-24 |