VIDAS? CMV IGM 30205

MAUDE Adverse Event Report

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..

Event Text Entries

[86104390] 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 1005685430), when compared to the specification the customer put in place, from results based on previous lots. Calibration values: compartment b1 - s1: bdf = 148/1125 rfv [714 - 1548], compartment b2 - s1: bdf = 144/1050 rfv, compartment b3 - c1: bdf = 144/1614 rfv vt = 1. 48 [1. 12 - 1. 60], compartment b4 - c2: bdf = 144 / -6 rfv vt = 0 [ equivocal (not conformed), (b)(6) 2017: bdf = 146/863 rfv / vt = 0. 79 => equivocal (non-compliant), (b)(6) 2017: bdf = 150/802 rfv / vt = 0. 73 => equivocal (not conformed), (b)(6) 2017: bdf = 157/920 rfv / vt = 0. 82 => 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 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

MAUDE Entry Details

• Report Number: 3002769706-2017-00275
• MDR Report Key: 6848963
• 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: 2017-05-15
• 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

Device Details

• Brand Name: VIDAS? CMV IGM
• Generic Name: VIDAS? CMV IGM
• Product Code: LKQ
• Date Received: 2017-09-07
• 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

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-09-07