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 2017-09-07 for VIDAS? CMV IGM 30205 manufactured by Biomerieux, S.a..
[86843765]
A customer from (b)(6) reported to biom? Rieux out of range low results when testing the internal quality control virotrol from bio-rad in association with vidas? Cmv igm (lot 1005712890), when compared to the specification the customer put in place, from results based on previous lots. Calibration values: compartment a1 - s1 : bdf = 146 / 1120 rfv [728 - 1577]. Compartment a2 - s1 : bdf = 145 / 1088 rfv. Compartment a3 - c1 : bdf = 146 / 1568 rfv vt = 1. 42 [1. 16 - 1. 65]. Compartment a4 - c2 : bdf = 147 / -8 rfv vt = 0 [< ou = 0. 69]. Lot 1005712890 cqi values obtained: (b)(6) 2017 : bdf = 147 / 933 rfv / vt = 0. 84 =>equivocal (not conformed). (b)(6) 2017 : bdf = 157 / 913 rfv / vt = 0. 80 =>equivocal (non-compliant). Recalibration with vortexing for 20 seconds and initiation of icq after homogenization by 20 turns resulted in the ciq as always equivocal. Compartment b1 - s1: bdf = 149/1155 rfv. Compartment b1 - s1: bdf = 149/1155 rfv. Compartment b2 - s1: bdf = 150/1269 rfv. Compartment b3 - c1: bdf = 147/1596 rfv vt = 1. 31. Compartment b4 - c2: bdf = 146 / -9 rfv / vt = -0. 00. Compartment b5 virotrol: bdf = 144/970 rfv / vt = 0. 80 => equivocal. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00276 |
| MDR Report Key | 6848975 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-07 |
| Date of Report | 2018-07-17 |
| Date Mfgr Received | 2018-06-20 |
| Device Manufacturer Date | 2017-05-29 |
| Date Added to Maude | 2017-09-07 |
| 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 | 2017-09-07 |
| Catalog Number | 30205 |
| Lot Number | 1005712890 |
| ID Number | 03573026064396 |
| Device Expiration Date | 2018-03-28 |
| 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 | 2017-09-07 |