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

Catalog Number	08837031190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas 6000 e601 module (serial number: (b)(6).The investigation determined that the anti-hcv ii assay performed within specifications.The specificity of the assay, as outlined in the method sheet, allows for the occurrence of single false positive results.Two patient samples collected on (b)(6) 2022 were tested on a cobas e 602 module using the anti-hcv ii reagent and generated reactive results of 1.75 coi and 1.86 coi.These samples were also tested using the fujirebio innolia hcv score assay, which generated negative results.Calibration data from the customer site showed slightly higher-than-expected signals for cal1 and slightly lower-than-expected signals for cal2, but these deviations were not deemed to impact assay performance.No sample material was provided for the investigation of the progba external control.The root cause of the reported false positive results was attributed to the assay's specificity limitations.The device remains in operation at the customer site.
Event or Problem Description
The initial reporter alleged a false positive result for one patient sample tested with the anti-hcv g2 elecsys cobas e 200 v2 assay on the cobas 6000 e601 module.Additionally, an external control (progba) was tested and generated a reactive result on roche instruments, which was expected to be non-reactive.The patient sample was initially tested on (b)(6) 2021 using the cobas 6000 e601 module and generated a reactive result.The same sample was tested on the abbott architect system on the same date and generated a negative result.On (b)(6) 2021, the sample was retested on the cobas 6000 e601 module and again generated a reactive result.In (b)(6) 2021, a new sample from the same patient was tested on the cobas 6000 e601 module and generated a reactive result.The same sample was also tested on the abbott architect system and generated a reactive result.No confirmatory testing by immunoblot was performed.Two additional samples from the same patient, collected on (b)(6) 2022, were tested on the cobas e 602 module using the anti-hcv ii reagent and generated reactive results of 1.75 coi and 1.86 coi.These samples were also tested using the fujirebio innolia hcv score assay, which generated negative results.
Additional Manufacturer Narrative
Correction - b5 originally stated the following: "two additional samples from the same patient, collected on (b)(6) 2022, were tested on the cobas e 602 module using the anti-hcv ii reagent and generated reactive results of 1.75 coi and 1.86 coi.These samples were also tested using the fujirebio innolia hcv score assay, which generated negative results." b5 should be updated to state: two additional samples from the same patient were collected on an unknown date and tested on a cobas e 602 module used for investigation and using the anti-hcv ii reagent, generating reactive results of 1.75 coi and 1.86 coi.These samples were also tested using the fujirebio innolia hcv score assay, which generated negative results.Correction - h11 originally stated the following: two patient samples collected on (b)(6) 2022 were tested on a cobas e 602 module using the anti-hcv ii reagent and generated reactive results of 1.75 coi and 1.86 coi.These samples were also tested using the fujirebio innolia hcv score assay, which generated negative results.H11 should be updated to state: two additional samples from the same patient were collected on an unknown date and tested on a cobas e 602 module used for investigation and using the anti-hcv ii reagent, generating reactive results of 1.75 coi and 1.86 coi.These samples were also tested using the fujirebio innolia hcv score assay, which generated negative results.

• 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: 23067089
• Report Number: 1823260-2025-02942
• Device Sequence Number: 9671719
• Product Code: MZO
• UDI-Device Identifier: 07613336166970
• UDI-Public: 07613336166970
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• 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,Followup
• Report Date (Section B): 10/16/2025

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: 02/28/2022
• Device Catalogue Number: 08837031190
• Device Lot Number: 545636
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/16/2025
• 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