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

Model Number	DHEAS
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Annual maintenance and an exchange of the gear pump head were performed on the first e 801 analyzer.The customer reported no further issues.
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with the elecsys pth immunoassay and elecsys dhea-s on a cobas 8000 e 801 module.The sample also had a questionable pth value when tested on a second e 801 analyzer.No incorrect results were reported outside of the laboratory.This medwatch will apply to the dhea-s assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the pth assay.The sample initially resulted in a pth value of < 1.5 pg/ml with a data flag when tested on the first e 801 analyzer.The sample was tested again on a second e 801 analyzer, resulting in the same value.The sample was frozen and re-tested approximately 1 week later on an abbott alinity analyzer, resulting in a pth value of 44.1 pg/ml.The sample initially resulted in a dhea-s value of > 1000 ug/dl with a data flag when tested on the first e 801 analyzer.The sample was diluted 1:10 and repeated on the first e 801 analyzer, resulting in a value of approximately 1100 ug/dl.The sample was frozen and re-tested approximately 1 week later on an abbott alinity analyzer, resulting in a dhea-s value of 211.4 ug/dl.The results from the abbott alinity analyzer were believable as these corresponded with the patient's clinical history.The serial number of the first e 801 analyzer is (b)(4).The serial number of the second e 801 analyzer was requested, but not provided.
Additional Manufacturer Narrative
A sample from the patient was provided for investigation and the results obtained by the customer could be reproduced.
Additional Manufacturer Narrative
Further investigations of the patient's sample determined that it contains an interfering factor against the streptavidin component of the roche assay.Per product labeling: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.".

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15703493
• Report Number: 1823260-2022-03448
• Device Sequence Number: 12318798
• Product Code: JKC
• UDI-Device Identifier: 04015630940387
• UDI-Public: 04015630940387
• Combination Product (Y/N): N
• 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): 01/03/2023

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: 02/28/2023
• Device Model Number: DHEAS
• Device Catalogue Number: 07027192190
• Device Lot Number: 57284001
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Supplement Date Received by Manufacturer: 11/28/2022; 12/20/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 12/12/2022; 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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