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

Catalog Number	06368921160
Medical Device Problem Codes	False Positive Result (1227); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged a discrepant reactive result for a sample (vm-10) tested using the anti-hcv g2 elecsys assay on the cobas 6000 e601 module.The sample was part of an api survey, where the expected result was non-reactive.The initial test result for the sample was 1.40 coi (reactive).The sample was manually loaded into a primary tube.On (b)(6) 2020, the sample was retested on the same system, yielding a result of 1.45 coi (reactive).The sample was then sent to a sister hospital, where it was tested again and remained reactive.To verify the analyzer's performance, the customer reran a known negative sample, which produced a non-reactive result.Quality control (qc) was reported to be within specifications.The customer suspected a sample issue.
Additional Manufacturer Narrative
The reported event occurred on a cobas e601 analyzer (serial number: (b)(6)).The investigation determined that the anti-hcv ii assay performed within specifications.The survey sample vm-10 was derived from pooled and treated material, which does not represent a native single-donor sample.This was identified as the most likely root cause for the false positive result.The sample exhibited a result close to the cut-off (1.58 coi, reactive), which may lead to discrepant results.Calibration and quality control data were reviewed and confirmed to be within expected ranges.Additional testing using fujirebio inno-lia hcv score and mikrogen recomline hcv score displayed negative results for the sample.The reagent was confirmed to be performing as intended, and no general reagent-related issue was identified.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23094356
• Report Number: 1823260-2025-03161
• Device Sequence Number: 12933108
• Product Code: MZO
• UDI-Device Identifier: 07613336154304
• UDI-Public: 07613336154304
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P140021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2025

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: 09/30/2020
• Device Catalogue Number: 06368921160
• Device Lot Number: 45793300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown