MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS DHEA-S; DEHYDROEPIANDROSTERONE TEST SYSTEM

Catalog Number	07027192190
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	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable elecsys dhea-s result from the cobas e 801 analytical unit.The initial result was > 1000 mcg/dl, and the repeat result from an e 402 analyzer was 271 mcg/dl.The initial result was questioned by the provider and repeated.There was no corrected result reported.
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The full prescription name provided in concomitant medical product is: norgestimate-ethinyl estradiol (ortho-cyclen/sprintec).See the attachment "results - cn-1059433.Xlsx" for the additional results and information reported.It was also provided that the customer's qc was passing at the time of the events.The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch field b3 date of event has been updated.Medwatch section d10: concomitant medical products updated.Full prescription information: norgestimate-ethinyl estradiol (ortho-cyclen/sprintec) 0.25-0.035 mg oral tab.The patient for data reported in initial medwatch mfg report number 1823260-2025-02077 is documented as patient 4 in follow-up medwatch mfg report number 1823260-2025-02077-01.Moving forward, this patient will be referred to as patient 4.Patient 4 has pcos.The customer provided data for two additional patient samples with discrepant dhea-s results (patients 6 and 7).Patient 6's initial result on (b)(6) 2025 was >1000 mcg/dl, and the repeat result on the e 402 analyzer on (b)(6) 2025 was 911 mcg/dl.Patient 7's initial result on (b)(6) 2025 was >1000 mcg/dl, and the repeat result on the e 402 analyzer on (b)(6) 2025 was 873 mcg/dl.Patient 6 is a 15-year-old female with cushing's disease.Patient 7 is a 66-year-old male with adrenal cortical carcinoma.The investigation is ongoing.
Additional Manufacturer Narrative
Four patient samples were received for investigation.It is not clear which patients these samples correspond to.The investigation reproduced the results of >1000 ¿g/dl, with data flags for all four samples received.The ionify (lc-ms/ms) analysis confirmed truly supraphysiological dhea-s levels between 837.4 and 891.4 ¿g/dl for three samples.Comparison testing showed that while the elecsys results were high (>1000 ¿g/dl), the beckman results (~300-400 ¿g/dl) were significantly lower compared to the mass spectrometry results (~850 ¿g/dl).The elecsys results are closer to the ionify (lc-ms/ms) results compared to beckman.The ionify results confirm actual supraphysiologic patient concentrations (>800 ¿g/dl).This suggests an underlying adrenal (hormonal) pathology is present, rather than technical issues.Per product labeling, "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation did not identify a product problem.

• Brand Name: ELECSYS DHEA-S
• Common Device Name: DEHYDROEPIANDROSTERONE TEST SYSTEM
• 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: 22435553
• Report Number: 1823260-2025-02077
• Device Sequence Number: 11551466
• Product Code: JKC
• UDI-Device Identifier: 04015630940387
• UDI-Public: 04015630940387
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K003174
• 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,Followup,Followup
• Report Date (Section B): 03/24/2026

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: 02/28/2026
• Device Catalogue Number: 07027192190
• Device Lot Number: 815067
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 08/21/2025; 10/27/2025; 03/06/2026
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 09/08/2025; 11/21/2025; 03/24/2026
• 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: NORGESTIMATE-ETHINYL ESTRADIOL (ORTHO-CYCLEN) -PT4; PATIENT 4 - NORGESTIMATE-ETHINYL ESTRADIOL -ORTHO-
• Patient Sex: Unknown