MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS MPX TEST, CE-IVD; ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA

Catalog Number 06997708190

Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

A supplemental mdr will be submitted upon completion of the investigation.(b)(4).

Event Description

A customer in the united (b)(6) alleged a false non-reactive hcv results for a serology-positive sample when tested with the cobas 6800 mpx test (lot g01162).The blood was not released and no harm or injury was alleged.

Manufacturer Narrative

No issues were identified with the complaint kit lot during the course of the investigation.Additionally, viral load testing was performed on two aliquots from the alleged donor sample to determine the viral load for hcv, using the abbott realtime hcv viral load test.Testing was performed by a third party external lab.The results for both aliquots of the donor sample with the abbot realtime viral load hcv assay were target not detected.No definitive conclusions can be drawn from the abbott realtime hcv viral load test results as the samples were received thawed prior to testing at the third party external lab.(b)(4).

• Brand Name: COBAS MPX TEST, CE-IVD
• Type of Device: ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• MDR Report Key: 11171967
• MDR Text Key: 272885803
• Report Number: 2243471-2021-00067
• Device Sequence Number: 1
• Product Code: QHO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 06997708190
• Device Lot Number: G01162
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1