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

Catalog Number 06997708190

Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going; a supplemental mdr will be filed upon completion of the investigation.(b)(6).The material number for the cobas mpx test, 96 t us-ivd is 06998909190.(b)(4).

Event Description

A customer in (b)(6) alleged (b)(6) results for a stem cell donation tested with the cobas mpx test (lot g17787).The stem cells were transplanted and there is no indication of harm to any recipient.The investigation is on-going.

Manufacturer Narrative

No product issue was identified during the course of the investigation of the kit lot.Although it could not be confirmed, the reactive results generated may be truly related to hiv sequences in the sample, of unclear origin.These reactive results could represent sample contamination if both tubes are from the same source or were open in the lab at the same time.Roche medical affairs department noted that there are also other possibilities of sources of hiv sequences, for example, if the donor was treated with gene therapy prior to the collection of the (b)(6) 2021 sample.Some gene therapy methods use vectors containing hiv ltr sequences.However, this could not be verified.Sample material of the donor in question was requested but was not available for further evaluation and analysis.(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. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• MDR Report Key: 11958699
• MDR Text Key: 280824282
• Report Number: 2243471-2021-01678
• 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: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 06997708190
• Device Lot Number: G17787
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1