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 2017-09-06 for VIDAS? CMV IGM 30205 manufactured by Biomerieux, Sa.

Event Text Entries

[86577898] A customer in (b)(6) notified biom? Rieux of low out of range accurun 26 internal quality control results for vidas? Cmv igm, lot 1005712890. Calibration cmvm - compliance ((b)(6) 2017): s1: bdf = 139 rfv = 1225, bdf = 142 rfv = 1377, [728-1577 rfv]. C1: compartment a3 bdf = 135 rfv = 1696 result = 1. 30 positive, [1. 16-1. 65]. C2: compartment b1 bdf = 144 rfv = -6 result = 0. 00 negative, [ (error suspected by customer). Two / compartment a1 bdf = 142 rfv = 1751 result = 1. 55 positive, [1. 21 - 1. 48] mean = 1. 34. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health. There was no patient associated with this discrepant quality control result. A biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3002769706-2017-00273
• MDR Report Key: 6846735
• Report Source: FOREIGN,HEALTH PROFESSIONAL,U
• Date Received: 2017-09-06
• Date of Report: 2018-07-17
• Date Mfgr Received: 2018-06-20
• Device Manufacturer Date: 2017-05-29
• Date Added to Maude: 2017-09-06
• 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: HAZELWOOD MO 63042
• Manufacturer Country: US
• Manufacturer Postal: 63042
• Manufacturer Phone: 3147317301
• Manufacturer G1: BIOMERIEUX, SA
• Manufacturer Street: 376 CHEMIN DE L'ORME
• Manufacturer City: MARCY L'ETOILE, 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: 2017-09-06
• Catalog Number: 30205
• Lot Number: 1005712890
• 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, SA
• Manufacturer Address: 376 CHEMIN DE L'ORME MARCY L'ETOILE, 69280 FR 69280

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-09-06