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

Catalog Number	07026838190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable false positive elecsys anti-hbe results from the cobas e 801 analytical unit that did not match the diagnosis of the patient.The customer suspected an interference.The result was 0.00611 coi and was confirmed by two repeat tests with the same result (0.00625 coi and 0.00618 coi).Results for the entire hepatitis b profile for the same patient sample were all negative.Ahbs result was <2 iu/l.Ahcv result was 0.033 coi (negative).Hbe_ag result was 0.0812 coi (negative).Hbsag result was 0.365 coi (negative).Ahbc was 1.34 coi (negative).
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Sample material from the patient was submitted for investigation.The anti-hbe result was 0,00590 coi (reactive).Neutralization revealed a very high change of the coi-value after the neutralization with hbeag coupled sepharose.Therefore, the sample was confirmed to be reactive.The investigation determined there was no product problem, and the assay performed within specifications.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21354454
• Report Number: 1823260-2025-00396
• Device Sequence Number: 20754376
• Product Code: LOM
• UDI-Device Identifier: 04015630940134
• UDI-Public: 04015630940134
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 05/19/2025

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: 06/30/2026
• Device Catalogue Number: 07026838190
• Device Lot Number: 82385901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 05/19/2025
• 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