MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS SHBG; TESTOSTERONE TEST SYSTEM

Catalog Number	03052001160
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 6000 e 601 module is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable elecsys shbg result from one patient sample tested on the cobas 6000 e 601 module.The initial result was not reported outside of the laboratory as the reporter suspected the initial result to be too low.The initial result was 0.92 nmol/l.The first repeat result was 30.93 nmol/l.The second repeat result was 27.37 nmol/l.The repeat results were deemed correct.
Additional Manufacturer Narrative
The investigation reviewed the calibration data and the signals were slightly higher than expected.The investigation reviewed the qc data and the results were within range before the patient sample run.A general reagent problem was not present because the qcs before the event were within range.Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS SHBG
• Common Device Name: TESTOSTERONE 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: 20304679
• Report Number: 1823260-2024-02766
• Device Sequence Number: 7745111
• Product Code: CDZ
• UDI-Device Identifier: 04015630939305
• UDI-Public: 04015630939305
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K102814
• 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): 10/14/2024

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: 11/30/2024
• Device Catalogue Number: 03052001160
• Device Lot Number: 74103101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/14/2024
• 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 Age: 50 YR
• Patient Sex: Male