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 Problems False Negative Result (1225); Non Reproducible Results (4029)

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

Event Date 09/14/2021

Event Type  malfunction  

Event Description

A customer in the (b)(6) alleged the generation of (b)(6) results with the cobas taqscreen mpx test, v2.0 for a patient who generated (b)(6) results.Patient was being screening for (b)(6) as a newly arrived expat.No donation was involved and no harm was alleged.

Manufacturer Narrative

The investigation is on-going.A supplemental report will be submitted upon completion of the investigation.(b)(4).

Manufacturer Narrative

Through the course of the investigation, a product non-conformance was not identified with the complaint kit lot.The sample was provided for further investigation.Viral load testing on 2 aliquots from the sample was performed by a third-party external lab using the abbott realtime viral load for hiv-1 test.No viral target was identified.Additional testing of the same aliquots was performed by roche using the cobas hiv 1/2 qualitative assay and both aliquots generated non-reactive results for hiv-1 and hiv-2.Roche medical and scientific affairs noted that hiv-2 infections in donors are rare, and a previous study from the american red cross reported very low viral loads in these donors.The potential and most likely causes for this pattern could be a false positive geenius result or a true hiv-2 infection with very low viral load below the roche tests' limit of detections.Based on the totality of the case, a product problem was not identified.Corrected device code from a090803 false negative result to a090806 test result - non reproducible.(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
• Manufacturer (Section G): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; na; branchburg NJ 08876
• Manufacturer Contact: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 12627733
• MDR Text Key: 281434838
• Report Number: 2243471-2021-03518
• Device Sequence Number: 1
• Product Code: QHO
• UDI-Device Identifier: 00875197004045
• UDI-Public: 00875197004045
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: BL125459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/13/2021
• Supplement Dates Manufacturer Received: 03/04/2022
• Supplement Dates FDA Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male