MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HCG STAT; HUMAN CHORIONIC GONADOTROPIN TEST

Catalog Number	08890595190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys hcg stat results from the cobas e 801 analytical unit.The initial result was 9.60 miu/ml.The patient's care provider questioned this result as the patient is on accutane, and it is required that they do not get pregnant, as this would be high-risk.The same sample was repeated on the same analyzer and another cobas e801 analyzer, and the results were <1 miu/ml with a data flag.On (b)(6) 2026, the same sample was repeated on the same analyzer and another cobas e801 analyzer, and the results were <1 miu/ml with a data flag.The repeat results were believed to be correct.
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
A general reagent or analyzer problem was not present, because the qc prior to the event was within ranges.No relevant alarms were present in the analyzer alarm trace.The customer and service maintenance are complete according to the specifications.The investigation was unable to determine a specific root cause.There was no product problem identified.

• Brand Name: ELECSYS HCG STAT
• Common Device Name: HUMAN CHORIONIC GONADOTROPIN 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: 24660843
• Report Number: 1823260-2026-01027
• Device Sequence Number: 12025643
• Product Code: DHA
• UDI-Device Identifier: 07613336169223
• UDI-Public: 07613336169223
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K203227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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 Catalogue Number: 08890595190
• Device Lot Number: 86902501
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/24/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACCUTANE.
• Patient Age: 18 YR
• Patient Sex: Female