MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. COBAS MPX TEST, CE-IVD; ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA

Catalog Number 06997716190

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation of this issue is on-going and final conclusions will be shared in a follow-up report.The material number for the cobas mpx test, 480t, (b)(4).The udi for the cobas mpx test, 480t, us-ivd is (b)(4).------ (b)(4).

Event Description

A customer from (b)(6) alleged discrepant results between serology and cobas mpx testing for a donor, with the cobas mpx test consistently generating non-reactive results.Depending on the serology test used, a mixture of positive and negative serology results were generated.The donor was diagnosed with lymphadenopathy, and it was indicated that he is a new donor.The blood donation was discarded.

Manufacturer Narrative

The donor sample from (b)(6) 2019 collection was sent to a reference lab for testing with the abbott real-time hiv-1 viral load assay.The result was target not detected, which confirms (b)(6) was not present and additional testing, including sequence analysis, would not be possible.No information was provided on any additional follow up blood draws or testing for the donor.Roche medical and scientific affairs was consulted with details of the case provided.They explained that a (b)(6) antigen test ten days following the first reaction, with no serology reactivity is unlikely for a true (b)(6) patient.With the totality of the data considered, as well as the investigation (review of qc kit release, non-conformance, etc) the cobas mpx assay has been determined to be functioning as intended.A (b)(6) result with the p24 and serology test assay is suspected.------ (b)(4).

• Brand Name: COBAS MPX TEST, CE-IVD
• Type of Device: ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC.; 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: 9639112
• MDR Text Key: 184179527
• Report Number: 2243471-2020-00002
• Device Sequence Number: 1
• Product Code: QHO
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 06997716190
• Device Lot Number: E21552
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2019
• 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 Age: 19 YR