MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS AMPLIPREP/COBAS TAQMAN HIV-1 TEST, V2.0; TEST, HIV DETECTION

Catalog Number	05212308190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analysis was performed on a cobas ampliprep instrument (serial number: (b)(6)).The investigation determined that the kit cap-g/ctm hiv-1 v2.0 us-ivd assay performed within specifications.A review of the risk assessment confirmed that the risks associated with the assay are acceptable, and no additional actions were required.The root cause of the reported event was confirmed to be unrelated to a product issue.The device remains in operation at the customer site, and no permanent harm to the patient or newborn was reported as a result of the event.
Event or Problem Description
The initial reporter alleged a false positive result using the kit cap-g/ctm hiv-1 v2.0 us-ivd on the cobas ampliprep instrument.The patient, a pregnant woman, had previously tested negative for hiv on an hiv 1/2 antibody/antigen screen conducted six months earlier in (b)(6) 2020.On (b)(6) 2021, the patient was tested using an hiv 4th generation antibody/antigen rapid screen, which generated a presumptive positive result.A reflex test was performed on the same sample using the hiv 1/2 differential assay (biorad genius supplemental assay), which reported a non-reactive result.On (b)(6) 2021, the customer conducted a polymerase chain reaction (pcr) test using the kit cap-g/ctm hiv-1 v2.0 us-ivd, which generated a positive result.The positive pcr result led to the initiation of a three-drug treatment regimen for the patient¿s newborn baby.

• Brand Name: COBAS AMPLIPREP/COBAS TAQMAN HIV-1 TEST, V2.0
• Common Device Name: TEST, HIV DETECTION
• 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; branchburg NJ 08876
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250 ; 9253534412
• MDR Report Key: 23064623
• Report Number: 2243471-2025-02914
• Device Sequence Number: 21343134
• Product Code: MZF
• UDI-Device Identifier: 00875197003024
• UDI-Public: 00875197003024
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: BP050069-20
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 05212308190
• Device Lot Number: G24809
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown