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	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys anti-hbe results from four patient samples tested on the cobas e 801 analytical unit.Two examples of discrepant results were provided: patient sample 1 the initial result from the analyzer was 0.64 cut-off index (coi).The first repeat result from the analyzer after high-speed centrifugation was the same.The second repeat result from a "domestic instrument" was 1.24 peiu/ml (negative).Patient sample 2 the initial result from the analyzer was 0.22 coi.The first repeat result from the analyzer after high-speed centrifugation was the same.The second repeat result from a "domestic instrument" was 0.98 peiu/ml (negative).The initial results were not reported outside of the laboratory as they did not match the patient's clinical diagnosis, alerting them to an issue with the results.The repeat results were reported.
Additional Manufacturer Narrative
The serial number of the customer's cobas e 801 analytical unit (b)(6).The investigation is ongoing.E1 initial reporter street line 1, e1 initial reporter street line 2: (b)(6).
Additional Manufacturer Narrative
The calibration results are valid and within the specified ranges.However, the calibration signal, especially the high-level signal, has decreased by 10% since (b)(6) 2025.The qc results are valid and within the specified ranges.The alarm trace had multiple sample barcode reading errors, a sample clot detection alarm, and a sample foam detection alarm.The patient sample tube was centrifuged at 3800 rpm for 10 minutes; the patient sample tube requires a longer centrifugation time and higher speed.A general reagent problem was not detected because the provided qc and calibration data were within specifications.The cause of the event could not be determined.

• 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: 21697048
• Report Number: 1823260-2025-00883
• Device Sequence Number: 18325510
• 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): 06/30/2025

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: 08/31/2025
• Device Catalogue Number: 07026838190
• Device Lot Number: 75879901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 06/30/2025
• 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