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

Model Number	HCG+BETA
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 2 samples from the same patient's blood draw tested with elecsys hcg+ss assay on a cobas e 801 analytical unit.Sample 1: the initial result was <0.200 miu/ml (tested in a gel tube: bd vacutainer) and accompanied by a data flag.The laboratory has a standard practice to retest some samples from the same patient using different tubes.The 1st repeat result was 9.81 miu/ml (tested in a tube without gel: bd red cap).On 21-mar-2026: a new blood sample (sample 2) was drawn and tested, resulting in the following: <0.200 miu/ml (tested in a gel tube: bd vacutainer) and accompanied by a data flag.<0.200 miu/ml (tested in a tube without gel: bd red cap) and accompanied by a data flag.Sample 2 was sent to a different laboratory and retested, resulting in an hcg+ss of <0.2 miu/ml.On 23-mar-2026: sample 1 (tube without gel: bd red cap) was repeated, and the 2nd repeat result was 12.9 miu/ml.No questionable results were reported outside the laboratory.The result of <0.200 miu/ml, accompanied by a data flag indicating a negative result, was deemed correct and reported to the patient.
Additional Manufacturer Narrative
The field service engineer checked the analyzer and performed an intensive troubleshooting of the provided data and confirmed no issues with the analyzer.The instrument was performing within specifications.A general reagent or analyzer problem can be excluded since the qc prior to the event was within ranges.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 24846291
• Report Number: 1823260-2026-01393
• Device Sequence Number: 17548911
• Product Code: DHA
• UDI-Device Identifier: 04015630939732
• UDI-Public: 04015630939732
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 05/08/2026

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: 09/30/2026
• Device Model Number: HCG+BETA
• Device Catalogue Number: 07251025190
• Device Lot Number: 86890601
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 05/08/2026
• 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: Unknown