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	05/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys anti-hcv ii results for one patient tested with a cobas 8000 e 801 module serial number (b)(4).The patient's sample was tested on the e 801 module on (b)(6) 2022 and on (b)(6) 2022.The elecsys anti-hcv results were reported outside the laboratory.On (b)(6) 2022 and (b)(6) 2022, the patient's sample was tested on a mini vidas biomerieux analyzer.On (b)(6) 2022, the patient's initial elecsys anti-hcv result was 0.0383 coi non-reactive.On (b)(6) 2022, the patient's initial mini vidas biomerieux anti-hcv result was 2.38 coi reactive.On (b)(6) 2022, the patient's first repeat mini vidas biomerieux anti-hcv result was 4.42 coi reactive.On (b)(6) 2022, the patient's second repeat mini vidas biomerieux anti-hcv result was 4.28 coi reactive.On (b)(6) 2022, the patient's repeat elecsys anti-hcv result was 0.0384 coi non-reactive.
Additional Manufacturer Narrative
The patient's sample was requested for an investigation, but the customer reported there was not enough sample left to provide for an investigation.The investigation is ongoing.
Additional Manufacturer Narrative
The customer confirmed the patient's sample was not confirmed by immuno-blot.The investigation reviewed the customer's qc results and the results were within the acceptable ranges.The field service engineer stated the customer is working correctly according to qc specifications and performs maintenance on the analyzer.Based on the provided information, the investigation did not identify a product problem.The cause of the event could not be determined.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 14980279
• Report Number: 1823260-2022-02038
• Device Sequence Number: 5690490
• Product Code: MZO
• UDI-Device Identifier: 04015630939947
• UDI-Public: 04015630939947
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 08/03/2022

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: 01/31/2023
• Device Catalogue Number: 07026889190
• Device Lot Number: 58790601
• 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: 06/17/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 08/03/2022
• 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: 23 YR
• Patient Sex: Male
• Patient Weight: 87 KG