MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. 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 Insufficient Information (4580)

Event Date 07/09/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A customer in (b)(6) alleged the generation of a (b)(6) result for a donation tested with the cobas taqscreen mpx test, v2.0.The donation was transfused into a recipient, who was confirmed to be (b)(6) by the local center of infectious disease.An investigation is on-going.

Manufacturer Narrative

The current investigation of the kit lots, including review of the qc kit release and manufacturing records, did not confirm a product issue.The investigation is on-going and a supplemental report will be submitted as additional conclusions become available.(b)(4).

Manufacturer Narrative

The current investigation of the kit lots, including review of the qc kit release and manufacturing records, did not confirm a product issue.Roche¿s medical affairs department was consulted and following assessment was provided.The april 15th donation was reportedly seronegative and nat negative in a pool of 6 on the cobas taqscreen mpx test, v2.0.Based on reported results of later samples from the donor and recipient, it seems that the donor developed an hiv infection and most likely had a very early hiv infection at the time of the april donation.Given that this was a very early infection, prior to the development of antibodies, it is likely that the viral concentration at the time of the april donation was very low.It is reported that a new blood draw on june 30th was hiv positive on cobas taqscreen mpx test, v2.0.This indicates that the infection is detectable with the cobas taqscreen mpx test, v2.0 and suggests that the initial non-detection was indeed related to a low viral load and not due to a sequence variation.The donor sample was requested for further evaluation and investigation; however, upon arrival, it was noted to have thawed during transport.As such, since the sample quality and integrity was compromised, investigative testing of the sample was not pursued.Per the instructions for use, detection of hiv-1 group m rna, hiv-1 group o rna, hiv-2 rna, hcv rna, and hbv dna is dependent on the number of virus particles present in the specimen and may be affected by specimen collection methods, storage, patient factors (i.E.Age, presence of symptoms), and/or stage of infection and pool size.(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.; 1080 us highway 202 south; branchburg NJ 08876
• MDR Report Key: 12274975
• MDR Text Key: 265015470
• Report Number: 2243471-2021-02814
• Device Sequence Number: 1
• Product Code: QHO
• UDI-Device Identifier: 00875197004045
• UDI-Public: 00875197004045
• Combination Product (y/n): N
• PMA/PMN Number: 125459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 05969484190
• Device Lot Number: G22253
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 08/04/2021
• Supplement Dates Manufacturer Received: 09/28/2021; 10/22/2021
• Supplement Dates FDA Received: 10/06/2021; 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other