MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HBC IGM; HEPATITIS B TEST

Catalog Number	07026811160
Medical Device Problem Codes	False Positive Result (1227); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e801 analyzer is (b)(6).The field service engineer could not determine a cause, but stated it may be related to consumables.The probes, water pressure, and rinsing stations were checked; all were acceptable.Precision studies were performed for anti-hbc igm and recovered within guidelines.The customer verified that anti-hbc igm controls recovered within the assigned ranges.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable results for samples from four patients tested with elecsys anti-hbc igm and elecsys anti-hbc ii.The results measured by each assay were alleged to be inconsistent with each other.This medwatch will apply to the elecsys anti-hbc igm reagent.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the elecsys anti-hbc ii reagent.All four patients had multiple samples drawn at the same time.All samples had positive anti-hbc igm results, but negative anti-hbc results.No specific data was provided.The patients' results were reported to the medical director.The medical director reviewed the cases and reported the patients as negative for hepatitis b based on the anti-hbc results, patient history, and clinical health of the patients at the time of sample collection.
Additional Manufacturer Narrative
The customer verbally stated that calibration and controls were acceptable.The patient samples were requested for investigation, but these were not available.Upon review of the alarm trace, sample clot detection and sample short errors were observed.These are indicators of possible poor sample quality.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS ANTI-HBC IGM
• Common Device Name: HEPATITIS B TEST
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20420488
• Report Number: 1823260-2024-02948
• Device Sequence Number: 8445013
• Product Code: LOM
• UDI-Device Identifier: 07613336153932
• UDI-Public: 07613336153932
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P110022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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: 05/31/2025
• Device Catalogue Number: 07026811160
• Device Lot Number: 819879
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 10/30/2024
• 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