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

Catalog Number	07026889190
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was requested for investigation.Both of the qc levels were near target or clearly within range.The signals for the calibration performed on (b)(6) 2022 were as expected and are valid.The calibration and qc data did not indicate an issue.The reagent performed within specifications.
Event or Problem Description
The initial reporter stated they received a false-negative elecsys anti-hcv ii immunoassay result for one patient sample tested on a cobas e 801 analytical unit with serial number (b)(4).It was unknown if the initial result was reported outside of the laboratory.The initial result from the analyzer at 10:36 was 0.0316 coi (non-reactive).The result from the vidas analyzer was 6.9 (positive).The unit of measurement was not provided.The result from the biorad immunoblot was negative, with a non-structural protein 3 (ns3) finding of "doubt".The result from the architect was 11.43 (positive).The unit of measurement was not provided.
Additional Manufacturer Narrative
Details regarding the biorad immunoblot result of "negative (ns3 doubt)" were requested but not provided.The sample was not provided for investigation.No further investigation was possible.Even if the elecsys result was a false negative, the specification would still be fulfilled.Single false-negative results can occur based on sensitivity.Product labeling states: "false negative results may occur due to antibody levels below the detection limit of this assay or if the patient ´s antibodies do not react with the antigens used in this test.".

• Brand Name: ELECSYS ANTI-HCV II
• Common Device Name: 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: 14051087
• Report Number: 1823260-2022-00977
• Device Sequence Number: 4753111
• Product Code: MZO
• UDI-Device Identifier: 04015630939947
• UDI-Public: 04015630939947
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P140021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 07026889190
• Device Lot Number: 567629
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male