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

Catalog Number	07027192190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant high results for 2 patient samples tested for elecsys dhea-s (dhea-s) on a cobas e 801 analytical unit compared to a competitor method.Patient 01: the initial result from the e801 analyzer was > 1000 g/dl.The sample was sent to an external laboratory using the beckman coulter dxi 800 and the result was 710 g/dl.Patient 02: the initial result from the e801 analyzer was > 1000 g/dl.The sample was sent to an external laboratory using the beckman coulter dxi 800 and the result was 947.1 g/dl.The sample was run by liquid chromatography-mass spectrometry (lc-ms) method and the dhea-s result was 517.97 nmol/l.
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).The customer reports that qcs were on target.The investigation is ongoing.
Additional Manufacturer Narrative
On 19-aug-2024, the customer provided additional data regarding the event: the mass spectrometer result for dhea was 3.67 ¿g/dl.It was not specified whether the result was for patient 01 or patient 02.The samples were requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
The customer's calibration and qc results were within acceptable ranges.Two patient samples were received for investigation.The two patient samples were tested for the presence of an interferent and no interference was detected.The investigation confirmed that the customer's results were correct.The investigation excluded a general reagent issue.The investigation determined that the competitor and liquid chromatography-mass spectrometry (lc-ms) method results were consistent with the elecsys dhea-s assay results and the results were confirmed with patient 1's diagnoses.Product labeling states "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.Medwatch field b7 other relevant history was updated.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19793989
• Report Number: 1823260-2024-02106
• Device Sequence Number: 17920721
• Product Code: JKC
• UDI-Device Identifier: 04015630940387
• UDI-Public: 04015630940387
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2024

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: 02/28/2025
• Device Catalogue Number: 07027192190
• Device Lot Number: 75160903
• 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: 06/28/2024
• Supplement Date Received by Manufacturer: 08/19/2024; 10/29/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 09/05/2024; 11/25/2024
• 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