MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTIHCV II IMMUNOASSAY; ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS

Catalog Number 07026889190

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

The last calibration was performed on (b)(6) 2020, calibration signals are stable and unsuspicious.The sample was sent to roche for further investigation.It was tested on another cobas e 801 with (b)(6) results.It was also tested with 2 different immunoblots (innolia and microgen) with (b)(6) results.This event occurred in (b)(6).Unique identifier (udi) #: (b)(4).

Event Description

The initial reporter received a questionable elecsys (b)(6) immunoassay result for one patient with the cobas e 801 module serial number (b)(4).The initial result from the e801 was 0.0492 coi ((b)(6)).The (b)(6) western blot was (b)(6).The rna analysis with unknown assay was (b)(6).

Manufacturer Narrative

The customer's qc recovery was found to be acceptable.Based on calibration and qc data a general reagent issue could be excluded.The sample was tested with abbott architect and ortho hcv 3.0 elisa save which received positive results.The sample was tested with the monolisa hcv ag-ab ultra v2 enzyme immunoassay kit and received negative results.Further clinical history regarding the patient was not provided by the customer.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS ANTIHCV II IMMUNOASSAY
• Type of Device: ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11338232
• MDR Text Key: 232213675
• Report Number: 1823260-2021-00500
• Device Sequence Number: 1
• Product Code: MZO
• Combination Product (y/n): N
• PMA/PMN Number: P140021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07026889190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR