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 2017-09-05 for VIDAS? CMV IGM 30205 manufactured by Biomerieux, S.a..
[86579103]
A customer from (b)(6) reported to biom? Rieux out of range low results for an internal quality control sample (accurun reference a26-5006 lot 10158371) in association with vidas? Cmv igm (lot 1005685430) when compared to the specification the customer put in place based on results obtained on previous lots. (b)(6). A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3002769706-2017-00267 |
MDR Report Key | 6843798 |
Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
Date Received | 2017-09-05 |
Date of Report | 2017-09-06 |
Date of Event | 2017-06-23 |
Date Mfgr Received | 2017-08-03 |
Device Manufacturer Date | 2017-05-15 |
Date Added to Maude | 2017-09-05 |
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 | ST. LOUIS MO 63042 |
Manufacturer Country | US |
Manufacturer Postal | 63042 |
Manufacturer Phone | 3147317301 |
Manufacturer G1 | BIOMERIEUX, S.A. |
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? CMV IGM |
Generic Name | VIDAS? CMV IGM |
Product Code | LKQ |
Date Received | 2017-09-05 |
Catalog Number | 30205 |
Lot Number | 1005685430 |
ID Number | 03573026064396 |
Device Expiration Date | 2018-03-20 |
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, S.A. |
Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2017-09-05 |