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 Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation of this issue is on-going, and final conclusions will be shared in a follow-up report.The facility name is: (b)(6).The material number for the cobas mpx test, 96t, us-ivd is 06998909190.The udi number for the us-ivd test is (b)(4).(b)(4).

Event Description

A customer from germany alleged the generation of an unexpected non-reactive result for a sample when tested with the cobas® 6800/8800 mpx test.The sample was tested twice in the same test run.One replicate of the sample generated a hbv reactive result and the second generated a non reactive result.No blood donation was released, and no harm was alleged.

Manufacturer Narrative

Investigation identified that the both runs of the alleged sample had unusual growth curve shapes.The first run had an value that was just above the cutoff and was called reactive for hbv.The unusual shape was slightly more pronounced in the curve for the second run.The value for the second curve did not meet the cutoff and the sample was called non-reactive.A proactive asap update, which will return an invalid call in situations where there is a positive growth curve with an unusual shape, was made available prior to the occurrence reported by this customer.The customer was using the previous version of the asap when the discrepant results occurred.It was determined that the issue is not likely to cause any adverse health consequences because hbv infection is rare in blood donors and parallel serologic testing would likely trigger the need for additional testing, plus the low frequency that this defect has been observed.-------------------------------- (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: 10650596
• MDR Text Key: 210597596
• Report Number: 2243471-2020-00236
• Device Sequence Number: 1
• Product Code: QHO
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 06997708190
• Device Lot Number: F21681
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1