MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HCV II; ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS

Catalog Number 07026889190

Device Problem False Negative Result (1225)

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

Event Date 11/29/2021

Event Type  malfunction  

Event Description

The initial reporter stated they received false negative results for one patient sample tested with the elecsys anti-hcv ii immunoassay on two cobas 8000 e 801 module analyzers.The sample was initially tested on the customer's e 801 analyzer, resulting in an (b)(6) value of (b)(6).The initial value was reported outside of the laboratory to a physician.The sample was repeated using the abbott method, resulting in a (b)(6) value.The sample was provided for investigation where it was tested twice on a second e 801 analyzer, resulting in (b)(6) values of (b)(6) and (b)(6).The sample was repeated with a cleia method, resulting in a value of (b)(6).The sample was also repeated using the (b)(6) method on (b)(6) 2021 and (b)(6) 2021, resulting in a (b)(6) value ((b)(6) antigen regions are all (b)(6)).The serial number of the customer's e 801 analyzer was requested, but not provided.The lot number and expiration date of the (b)(6) used on this analyzer were requested, but not provided.The serial number of the e 801 analyzer used for investigation was (b)(4).(b)(6) reagent lot number 5676290, with an expiration date of 31-oct-2022 was used on this analyzer.

Manufacturer Narrative

The investigation determined that the sample is a true negative for the elecsys anti-hcv ii immunoassay based on the results of the blot method.A false reactive result with the competitor method is most likely.

• Brand Name: ELECSYS ANTI-HCV II
• Type of Device: ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13079391
• MDR Text Key: 290379738
• Report Number: 1823260-2021-03870
• Device Sequence Number: 1
• Product Code: MZO
• UDI-Device Identifier: 04015630939947
• UDI-Public: 04015630939947
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• 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, 5676290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2022
• 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
• Patient Sequence Number: 1