MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HBE; ANTI-HBE TEST

Model Number	D438570
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The qc recovery data provided was within specification.The patient sample was requested for investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys anti-hbe results for 1 patient on a cobas e 801 analytical unit compared to an abbott alinity analyzer.On (b)(6) 2026, the initial anti-hbe result was 0.813 coi, interpreted as reactive.The repeat result after recentrifugation of the patient sample was 0.765 coi, interpreted as reactive.These results were deemed "false positives", as the patient's other hepatitis b markers were "negative".On (b)(6) 2026, the repeat result of a portion of the patient's serum sample tested on the abbott alinity analyzer was 1.58 s/co, interpreted as non-reactive.
Additional Manufacturer Narrative
The alarm trace showed sample clot detection alarms.The patient sample was received for investigation.The investigation was able to confirm a heterophilic antibody interference in the patient sample.Per 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." no product problem was identified.

• Brand Name: ELECSYS ANTI-HBE
• Common Device Name: ANTI-HBE 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24500046
• Report Number: 1823260-2026-00756
• Device Sequence Number: 10486352
• Product Code: LOM
• UDI-Device Identifier: 04015630940134
• UDI-Public: 04015630940134
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P190005/S002
• 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): 05/20/2026

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 Model Number: D438570
• Device Catalogue Number: 07026838190
• Device Lot Number: 86694401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 05/20/2026
• 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 Age: 13 YR
• Patient Sex: Female
• Patient Race: Asian