MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HCG+SS; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Model Number	HCG+BETA
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable elecsys hcg+ss result from the cobas e 801 analytical unit for one patient.The initial result was 193 miu/ml, and the repeat result was 320 miu/ml.The repeat result on a cobas pure was 327 miu/ml.On (b)(6) 2026, the sample was repeated on the e 801 again with results of 333 miu/ml and 335 miu/ml.A previous result from (b)(6) 2026 of 241 miu/ml was available, and the customer noticed the difference and repeated the sample to confirm the result.
Additional Manufacturer Narrative
The qc was within range prior to the event.The alarm trace contained alarms for sample foam, sample short, and sample clot detection on the date of the event.A field service engineer (fse) performed a replacement of the gear pump head, cleaning of the procell flow line, verification of the pre-wash sipper, and verification of bubbles in the syringes.After the intervention, mechanism tests and verification of the analyzer's operation were performed, as well as conditioning of the measuring cells.No new events were reported after the service actions were completed.The investigation determined that the service action resolved the issue.

• Brand Name: ELECSYS HCG+SS
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• 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: 24428128
• Report Number: 1823260-2026-00654
• Device Sequence Number: 8132698
• Product Code: DHA
• UDI-Device Identifier: 04015630939732
• UDI-Public: 04015630939732
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K003178
• 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): 04/03/2026

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 Expiration Date: 05/31/2026
• Device Model Number: HCG+BETA
• Device Catalogue Number: 07251025190
• Device Lot Number: 868906
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/03/2026
• 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 Sex: Female