MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HAV II; HEPATITIS A TEST

Model Number	ANTI-HAV II
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Calibration results were acceptable.The 8 patient samples were submitted for investigation and tested on an e801 module with reagent lot 625717.Patient 1 result was (b)(6).Patient 2 result was (b)(6).Patient 3 result was 1.07 coi (non-reactive) patient 4 result was 1.07 coi (non-reactive) patient 5 result was 1.09 coi (non-reactive) patient 6 result was 1.04 coi (non-reactive) patient 7 result was 1.09 coi (non-reactive) patient 8 result was (b)(6).The results for all 8 samples were close to the cut-off value of 1.0 coi as observed by the customer.A product problem was not identified.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable results for 8 patient samples tested with the elecsys anti-hav ii on a cobas e 801 analytical unit, serial number (b)(6).The samples were discrepant positive when compared to the negative anti-hav results obtained in a different laboratory by using a competitor method from abbott.Patient 1 (sample from (b)(6) 2023) had an anti-hav ii result of(b)(6).Patient 2 (sample from (b)(6) 2023) had an anti-hav ii result of (b)(6).Patient 3 (sample from (b)(6) 2023) had an anti-hav ii result of (b)(6).Patient 4 (sample from (b)(6) 2023) had an anti-hav ii result of (b)(6).Patient 5 (sample from (b)(6) 2023) had an anti-hav ii result of (b)(6).Patient 6 (sample from (b)(6) 2023) had an anti-hav ii result of (b)(6).Patient 7 (sample from (b)(6) 2022) had an anti-hav ii result of (b)(6).Patient 8 (sample from (b)(6) 2023) had an anti-hav ii result of (b)(6).The positive anti-hav ii results were reported outside of the laboratory and questioned by the physician.
Additional Manufacturer Narrative
The 8 samples were investigated further.The samples for patient 3, patient 4, patient 5, patient 6, and patient 7 tested as non-reactive and are considered to be negative for anti-hav antibodies.The samples for patient 1 and patient 2 are considered to be true anti-hav positive.No interfering factors were identified.The sample for patient 8 may contain an interference against the anti-sulpho ruthenium antibodies component of the reagent causing the reactive result.This interference is addressed in product labeling: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design." the investigation did not identify a product problem.

• Brand Name: ELECSYS ANTI-HAV II
• Common Device Name: HEPATITIS A TEST
• 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: 16780964
• Report Number: 1823260-2023-01346
• Device Sequence Number: 6849579
• Product Code: LOL
• UDI-Device Identifier: 07613336129715
• UDI-Public: 07613336129715
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K190428
• 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): 06/02/2023

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: 07/31/2023
• Device Model Number: ANTI-HAV II
• Device Catalogue Number: 08086664190
• Device Lot Number: 62571701
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 06/02/2023
• 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 Sex: Unknown