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

Catalog Number 05969484190

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2019

Event Type  Injury  

Manufacturer Narrative

Medical opinion indicated that a (b)(6) nat would not prohibit the use of autologous stem cell products in the us; however, the institution's policy with regards to storage and distribution of such products or what the clinician would do is up to them.Although requested, it is unknown what decision was made for the affected autologous stem cell donor.There may be a potential delay in treatment pending further evaluation of the patient's infection status.However, no harm has been indicated to date.No issues were identified with the complaint kit lot during the investigation.The product common name was truncated and the complete name is "human immunodeficiency virus type 1 (hiv-1) group m rna, hiv-1 group o rna, human immunodeficiency virus type 2 (hiv-2) rna, hepatitis c virus (hcv) rna and hepatitis b virus (hbv) dna assay".(b)(4).

Event Description

A customer alleged a potential (b)(6) result while using the cobas taqscreen mpx test v2.An autologous stem cell donor obtained a (b)(6) with the cobas taqscreen mpx test v2 on (b)(6) 2019.This donor has tested (b)(6) with 3 collections in the previous 6 months ((b)(6) 2018, (b)(6) 2018, (b)(6) 2019), and 1 new collection ((b)(6) 2019).The donor was serology (b)(6).No harm has been indicated to date.

• Brand Name: COBAS TAQSCREEN MPX TEST V2
• 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 hwy 202 s; branchburg NJ 08876
• Manufacturer Contact: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 8508696
• MDR Text Key: 141749489
• Report Number: 2243471-2019-00016
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2019

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: No Information
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 05969484190
• Device Lot Number: E10662
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 04/12/2019
• 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 Outcome(s): Other
• Patient Age: 4 YR