MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS COBAS TAQSCREEN MPX TEST, V2.0 CE-IVD; HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GROUP M AND O RNA, HIV-2 RNA, HCV

Catalog Number 05969492190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Non Reproducible Results (4029)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation into this issue is currently on-going.The outcome of this investigation will be communicated through a follow-up report.(b)(4).The corresponding us kit material number is 05969484190.(b)(4).

Event Description

A customer from (b)(6) reported that a donation was tested in a pool of 6 and generated a (b)(6) result.Resolution testing in idt confirmed the (b)(6) result.Serology results for this donation showed a negative result for (b)(6).It is clear for the customer that the (b)(6) result shows early stage of (b)(6) infection with no antibodies produced by the patient's organism.However, the customer is concerned about the (b)(6) result with cobas taqscreen mpx v2 test while serology was (b)(6).A new sample collection from the same donor was tested with the cobas 4800 (b)(6) test and generated a (b)(6).The donation was not released.

Manufacturer Narrative

Given the ct value for the hcv target on the nat test and the serology hcv negative result, it was concluded that this donor was in the early stages of hcv infection.For the non-reactive hiv result in nat, a new sample aliquot was obtained and tested on the cobas 4800 hiv-1 quantitative test.This test generated a viral load of 2.43 e+04 iu/ml for the hiv target, which confirms the donation was not a hiv low titer sample or a sample with a titer at or near the limit of detection (lod) of the assay.As the cobas 4800 hiv-1 test, which is a dual target assay, was able to amplify the hiv target contained in the donor sample, it is possible that the non-reactive result generated on the cobas taqscreen mpx v2.0 test was due to a sequence related issue.Although the sample was requested for sequencing, no sample or sequence result was provided for further analysis.Investigation of the reagent kit lot did not find any product problem.The product's method sheet indicates plasma from all donors may be screened as individual specimens.For donations of whole blood and blood components, plasma specimens may be tested individually or in pools comprised of aliquots of individual specimens in conjunction with serology tests for hiv, hcv and hbv.The method sheet also states, under the sections of procedural limitations: though rare, mutations within the highly conserved regions of a viral genome covered by the cobas taqscreen mpx test, v2.0 primers and/or probe may result in failure to detect a virus.Cn-560542.

• Brand Name: COBAS TAQSCREEN MPX TEST, V2.0 CE-IVD
• 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; 1080 us highway 202 south; branchburg NJ 08876
• MDR Report Key: 10984380
• MDR Text Key: 252880636
• Report Number: 2243471-2020-00449
• Device Sequence Number: 1
• Product Code: QHO
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 05969492190
• Device Lot Number: F21520
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1