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	12/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for four patient samples tested with the elecsys anti-hav ii on a cobas e 801 analytical unit, serial number 1983-05.The positive results did not fit the clinical history of the patients as no vaccination or infection is known/assumed.Patient 1: the sample initially resulted in an anti-hav ii value of 1.0 coi.A second sample drawn from the same patient resulted in an anti-hav ii value of 1.0 coi.The sample was then repeated in a different laboratory by using an immunoluminometric assay (ilma) method, showing a negative result.Patient 2: the sample initially resulted in an anti-hav ii value of 0.7 coi.A second sample drawn from the same patient resulted in an anti-hav ii value of 0.71 coi.The sample was then repeated in a different laboratory by using an immunoluminometric assay (ilma) method, showing a positive result.Patient 3: the sample initially resulted in an anti-hav ii value of 0.85 coi.A second sample drawn from the same patient resulted in an anti-hav ii value of 0.857 coi.The sample was then repeated in a different laboratory by using an immunoluminometric (ilma) assay method, showing a negative result.Patient 4: the sample initially resulted in an anti-hav ii value of 0.81 coi.A second sample drawn from the same patient resulted in an anti-hav ii value of 0.815 coi.The questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The samples from patients 4 and 5 were provided for investigation and tested on a cobas e801 module and a cobas e602 module.The elecsys anti-hav ii results close to the cut-off generated at the customer site could be reproduced.Both sample results were reactive for anti-hav ii.Patient 4: e801 module: 0.889 coi (reactive).E602 module: 0.885 coi (reactive).Patient 5: e801 module: 0.993 coi (reactive).E602 module: 0.994 coi (reactive).The samples were also tested on a cobas e801 module using the elecsys anti-hav igm assay, resulting in non-reactive values (patient 4: 0.312 coi and patient 5: 0.320 coi ).The investigation is ongoing.
Additional Manufacturer Narrative
The calibration and qc data provided were acceptable.The investigation determined that there were no interfering factors in the samples of patients 3 and 5.The reactive results for samples 3, 4, and 5 were deemed correct.Based on the available data, it was determined that the reagent performs within specification.The investigation did not identify a product problem.The root cause of the event could not be determined.
Additional Manufacturer Narrative
The customer provided data for one additional patient sample with questionable results tested with the elecsys anti-hav ii on a cobase 801 analytical unit.Patient 5: the sample initially resulted in an anti-hav ii value of 0.860 coi.The sample was then repeated in a different laboratory by using an immunoluminometric (ilma) assay method, showing a negative result.The questionable result was reported outside of the laboratory.Medwatch field b7 has been updated.
Additional Manufacturer Narrative
The sample from patient 4 was further tested with the abbott alinity anti-hav igg method, resulting in a negative (0.100 s/co) result.The investigation is ongoing.

• 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: 16122481
• Report Number: 1823260-2023-00088
• Device Sequence Number: 6533853
• Product Code: LOL
• UDI-Device Identifier: 07613336129715
• UDI-Public: 07613336129715
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup,Followup,Followup
• Report Date (Section B): 05/25/2023

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: 02/28/2023
• Device Model Number: ANTI-HAV II
• Device Catalogue Number: 08086664190
• Device Lot Number: 59180601
• 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: 12/19/2022
• Supplement Date Received by Manufacturer: 01/16/2023; 02/02/2023; 04/18/2023; 04/28/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 02/08/2023; 03/01/2023; 05/02/2023; 05/25/2023
• 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