MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS TAQSCREEN MPX TEST V2; HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GROUP M AND O RNA, HIV-2 RNA, HCV

Catalog Number 05969484190

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2021

Event Type  malfunction  

Event Description

A customer from (b)(6) alleged the generation of discrepant results compared to the serology result when using the cobas taqscreen mpx test, v2.0, lot h02619.A donation generated a non-reactive result in pool of 6 and the serology result was hcv reactive.Resolution testing in pool of 1 generated a hbv reactive result.Repeat of of the resolution testing in pool of 1 generated a non-reactive result.No harm was alleged.An investigation is on-going.

Manufacturer Narrative

An investigation is on-going.A supplemental report will be filed upon completion of the investigation.Facility name was truncated due to characters limits.The complete facility name is (b)(6).(b)(4).

Manufacturer Narrative

An investigation of the reagent kit lot h02619 did not identify any product issue.The alleged sample were returned for investigation.The returned sample was tested in triplicate, using a quantitative hcv test (cobas® hcv, processing volume 650ul) and the sample generated a hcv target not detected result for all 3 replicates.A possible cause for the hbv and hcv reactive results at the customer site could be a laboratory contamination; however, the customer stated it was unlikely as they did not know of any potential source of contamination in their lab.An occult hbv infection cannot be excluded but as they are rare it does seem unlikely.The customer further stated that they suspected potential false positive serology results as an explanation for the non-reactive nat results.(b)(4).

• Brand Name: COBAS TAQSCREEN MPX TEST V2
• Type of Device: HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GROUP M AND O RNA, HIV-2 RNA, HCV
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• MDR Report Key: 12492448
• MDR Text Key: 281734272
• Report Number: 2243471-2021-03300
• Device Sequence Number: 1
• Product Code: QHO
• UDI-Device Identifier: 00875197004045
• UDI-Public: 00875197004045
• Combination Product (y/n): N
• PMA/PMN Number: BL125459
• 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: 11/02/2021

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: 08/31/2022
• Device Catalogue Number: 05969484190
• Device Lot Number: H02619
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/17/2021
• Supplement Dates Manufacturer Received: 10/22/2021
• Supplement Dates FDA Received: 11/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1