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

Model Number	ANTI-HAV II
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of false positive results for 2 patients tested for elecsys anti-hav ii (anti-hav ii) on a cobas e 801 module.On (b)(6) 2022 patient 1 had an anti-hav ii result of 0.995 coi (positive).On (b)(6) 2023 a serum sample and a lithium-heparin sample were obtained.The results from the serum sample were 1.04 coi (negative), 1.05 coi (negative), and 1.06 coi (negative).The results from the lithium-heparin sample were 1.01 coi (negative), 1.00 coi (negative), and 0.993 coi (positive).On (b)(6) 2023 two lithium-heparin samples were obtained for patient 2.From sample id (b)(6) the results were 1.00 coi (negative), 0.992 coi (positive), and 1.00 coi (positive).From sample id (b)(6) the results were 0.998 coi (positive), 0.993 coi (positive), and 1.01 coi (negative).There was no centrifugation step between the results.All results were from the primary sample tube.The e801 module serial number was (b)(4).
Additional Manufacturer Narrative
Calibration and qc were acceptable.During a review of the alarm trace data, 10-12 sample quality related alarms per day were observed in dec-2022 and jan-2023.The gear pump head and measuring cell were replaced during the last maintenance visit in aug-2022.The samples were requested for investigation.
Additional Manufacturer Narrative
The patient samples were received for investigation.The anti-hav ii results for the patient samples were all negative: patient 1 results: 1.11 coi (negative), 1.16 coi (negative), 1.16 coi (negative), 1.03 coi (negative), 1.09 coi (negative), and 1.08 coi (negative).Patient 2 results: 1.04 coi (negative), 1.08 coi (negative), 1.07 coi (negative), 1.02 coi (negative), 1.07 coi (negative), and 1.03 coi (negative).The customer's observation was not reproduced during the investigation.A reagent issue was not identified.The reagent performs within specification.The investigation noted several sample quality related alarms which may be related to a maintenance issue at the customer site.

• 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: 16296064
• Report Number: 1823260-2023-00342
• Device Sequence Number: 12249497
• 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): N
• 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): 02/23/2023

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: 01/13/2023
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 02/23/2023
• 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