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 Problem No Patient Involvement (2645)

Event Date 07/31/2020

Event Type  Injury  

Manufacturer Narrative

Investigation of the complaint kit lot including review of the qc release data, internal non conformance and stability data, did not identify any product issue.There is not a complaint trend identified for the reagent lot.Review of the customer data showed the growth curve for the complaint sample is sigmoidal and shows signs of robust amplification; however, due to the late ct, the curve was cut off before it plateaued.The shape of the curve suggests that a true target was amplified.The late ct value is indicative of a titer near the limit of detection (lod), where sample results can be expected to waiver between reactive and non-reactive.The data seems to suggest that the reactive sample has an (b)(6) titer near the lod.However, it cannot be conclusively determined if the donation was truly infected or if the reactive call was due to other factors, such as cross-contamination, non-specific amplification or non-target amplification.The udi for the cobas taqscreen mpx test, v2.0, us-ivd is (b)(4).The corresponding us kit material number is 05969484190.(b)(4).

Event Description

A customer in (b)(6) alleged an unexpected (b)(6) result for a sample after 2 repeat, resolution testings generated (b)(6) results and serology was (b)(6).The customer decided to release the blood for use.However, it is not known how the blood was used, as that information is confidential.No harm has been alleged.

• 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
• Manufacturer Contact: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 10480106
• MDR Text Key: 205267903
• Report Number: 2243471-2020-00018
• Device Sequence Number: 1
• Product Code: QHO
• Combination Product (y/n): N
• Reporter Country Code: EC
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 05969492190
• Device Lot Number: F18345
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 09/01/2020
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other