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 07/17/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation is on-going.A supplemental report will be filed upon completion of the investigation.(b)(6).(b)(4).

Event Description

A customer from (b)(6) alleged the generation of discrepant results compared to the serology results for three(3) donations, when using the cobas taqscreen mpx test, v2.0, lot h02619.The blood donations were not released.No harm was alleged.An investigation is on-going.

Manufacturer Narrative

The customer initially alleged the generation of discrepant results compared to the serology results for three (3) donations, when using the cobas taqscreen mpx test, v2.0, lot h02619.During the investigation, the customer alleged 2 additional donations with discrepant results compared to the serology results.The data of the additional donation allegations have been added to b6.A possible cause for the hbv reactive results could be due to 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 seems unlikely to be the cause of the unexpected hbv nat reactive results in 5 different samples.The customer further stated that they suspected potential hiv false positive serology results as an explanation for the non-reactive hiv nat results.Investigation of the reagent kit lot h02619 did not identify any product issue.Samples from 3 of the 5 questioned donations were returned for investigation.The returned samples were tested in triplicates, using a quantitative hiv test with a dual target approach (cobas® hiv test).All 3 samples generated a hiv non-reactive result for all 3 replicates.This supports the customer¿s suspicion that these were potentially serology false positives and therefore not nat false negatives.(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: 12362418
• MDR Text Key: 282052905
• Report Number: 2243471-2021-03078
• 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: 10/26/2021

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: 07/26/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 10/22/2021
• Supplement Dates FDA Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1