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 2017-09-12 for VIDAS? CMV IGM 30205 manufactured by Biomerieux, S.a..
[87219420]
A customer in (b)(6) reported to biom? Rieux (b)(6) results in association with vidas? Cmv igm. On (b)(6) 2017, the customer was calibrating vidas? Cmv igm lot 1005824730, when a biorad virotrol quality control was performed. This quality control result was expected to be (b)(6), but was (b)(6) twice with index values at 0. 66 and 0. 69. The customer then tested a known (b)(6) male patient sample. The sample was expected to be (b)(6), but was (b)(6) when tested with vidas? Cmv igm. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00279 |
| MDR Report Key | 6860385 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-12 |
| Date of Report | 2018-07-18 |
| Date of Event | 2017-08-16 |
| Date Mfgr Received | 2018-06-20 |
| Device Manufacturer Date | 2017-07-21 |
| Date Added to Maude | 2017-09-12 |
| 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 | 2017-09-12 |
| Catalog Number | 30205 |
| Lot Number | 1005824730 |
| ID Number | 03573026064396 |
| Device Expiration Date | 2018-05-24 |
| 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 | 2017-09-12 |