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

Catalog Number	08836981190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The anti-hcv ii reagent expiration date was not provided.The reported event occurred on a cobas e411 disk analyzer (serial number: (b)(6).The investigation determined that the anti-hcv g2 elecsys assay performed within specifications.A review of quality control data confirmed that the results for the pc lot: 792497 were within the specified range of +/- 3sd.Calibration signals were also found to be inconspicuous.Instrument checks, including line and earthing voltage, reagent quality, and bead mixing, did not identify any anomalies.Pre-analytical factors were reviewed, and no issues were identified.The root cause was attributed to single false positive results, which are covered by the assay's specificity claim.The device remains in operation at the customer site, and no further issues have been reported.
Event or Problem Description
The initial reporter alleged three false positive results for the anti-hcv g2 elecsys cobas e 100 v2 assay on the cobas e411 disk analyzer.Between 20-dec-2023 and 10-jan-2025, 357 samples were tested for hepatitis c virus (hcv) at the customer site, and three samples were identified as false positive.On (b)(6) 2025, the three samples were retested on a cobas e 801 analyzer.Sample (b)(6) generated a result of 2.96 coi (reactive), sample (b)(6) generated a result of 1.89 coi (reactive), and no result was provided for sample (b)(6).Subsequent rna testing for all three samples was negative.

• 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: 23081532
• Report Number: 1823260-2025-03071
• Device Sequence Number: 15968627
• Product Code: MZO
• UDI-Device Identifier: 07613336166956
• UDI-Public: 07613336166956
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K221693
• 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
• Report Date (Section B): 09/18/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 08836981190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 09/18/2025
• 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