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 06997708190

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

Patient Problem Test Result (2695)

Event Date 02/19/2019

Event Type  Injury  

Manufacturer Narrative

An investigation was performed and no kit issues were identified relating to (b)(6) results.Based on the results generated for this donor, it is suspected that the donor was infected between (b)(6) 2018 and (b)(6) 2019, with a low level (b)(6) infection, which may not consistently be detected by the cobas mpx test, where serology was (b)(6) due to the lack of seroconversion (window period).The cobas mpx test, ce ivd instructions for use indicates "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 sample and may be affected by sample collection, storage and handling, patient factors (i.E., age, presence of symptoms), and/or stage of infection and pool size." the material number for the cobas mpx test, 96t, us-ivd is 06998909190.(b)(4).

Event Description

A (b)(6) customer alleged the generation of a (b)(6) sample tested with the cobas mpx test for use on the cobas 6800/8800 system ((b)(6) 2019) in pool of 8.As the result in (b)(6) 2019 matched (b)(6) serology results, the donation was released and there are two recipients of this donation.It is confirmed that one patient received the thrombocyte concentrate and is being monitored.There is no information regarding if the second patient received the erythrocyte concentrate.In (b)(6) 2019, the customer received an anonymous call requesting that the donor be drawn and tested again.A new donation and previous donations from (b)(6) 2019 and (b)(6) 2018 were tested in (b)(6) 2019.The new donation and the donation from (b)(6) 2019 generated (b)(6) results and the donation from (b)(6) 2018 generated (b)(6) results.The serology for this donor was (b)(6).

Manufacturer Narrative

Na.

Event Description

(b)(6) 2019, it was indicated that the second recipient received the erythrocyte concentration; this information was unknown at the time of filing the initial mdr report.Additionally, it was noted that both recipients have a viral load of 6.8-7*10^6 iu/ml, but it is unclear what test method was used to test the recipients.

• 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
• MDR Report Key: 8634629
• MDR Text Key: 145915319
• Report Number: 2243471-2019-00021
• Device Sequence Number: 1
• Product Code: MZP
• 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
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

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: 08/31/2020
• Device Catalogue Number: 06997708190
• Device Lot Number: E10866
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/22/2019
• Supplement Dates Manufacturer Received: 05/02/2019
• Supplement Dates FDA Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other