COBAS TAQSCREEN MPX TEST, VERSION 2.0

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-03 for COBAS TAQSCREEN MPX TEST, VERSION 2.0 manufactured by Roche Molecular Systems, Inc..

Event Text Entries

[74613908] False positive rates using the roche molecular systems, inc cobas taqscreen mpx test, version 2. 0 exceeded what is published in the package insert.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6547933
• MDR Report Key: 6547933
• Date Received: 2017-05-03
• Date of Event: 2017-03-31
• Date Facility Aware: 2017-04-01
• Report Date: 2017-04-26
• Date Reported to FDA: 2017-04-26
• Date Reported to Mfgr: 2017-04-26
• Date Added to Maude: 2017-05-05
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: COBAS TAQSCREEN MPX TEST, VERSION 2.0
• Generic Name: COBAS TAQSCREEN MPX TEST, VERSION 2.0
• Product Code: MZP
• Date Received: 2017-05-03
• Lot Number: X06559
• Device Expiration Date: 2018-03-31
• Device Availability: Y
• Device Age: 8 YR
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ROCHE MOLECULAR SYSTEMS, INC.
• Manufacturer Address: BRANCHBURG NJ US

Device Sequence Number: 2

• Brand Name: COBAS TAQSCREEN MPX TEST, VERSION 2.0
• Generic Name: COBAS TAQSCREEN MPX TEST, VERSION 2.0
• Product Code: MZP
• Date Received: 2017-05-03
• Lot Number: X07609
• Device Expiration Date: 2018-04-30
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: ROCHE MOLECULAR SYSTEMS, INC.
• Manufacturer Address: BRANCHBURG NJ US

Device Sequence Number: 3

• Brand Name: COBAS TAQSCREEN MPX TEST, VERSION 2.0
• Generic Name: COBAS TAQSCREEN MPX TEST, VERSION 2.0
• Product Code: MZP
• Date Received: 2017-05-03
• Lot Number: X08493
• Device Expiration Date: 2018-06-30
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: ROCHE MOLECULAR SYSTEMS, INC.
• Manufacturer Address: BRANCHBURG NJ US

Device Sequence Number: 4

• Brand Name: COBAS TAQSCREEN MPX TEST, VERSION 2.0
• Generic Name: COBAS TAQSCREEN MPX TEST, VERSION 2.0
• Product Code: MZP
• Date Received: 2017-05-03
• Lot Number: X12815
• Device Expiration Date: 2018-07-31
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: ROCHE MOLECULAR SYSTEMS, INC.
• Manufacturer Address: BRANCHBURG NJ US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-05-03