MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TESTOSTERONE II; RADIOIMMUNOASSAY, TESTOSTERONE

Catalog Number	07027915190
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	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable testosterone g2 elecsys results from the cobas e 801 analytical unit serial number (b)(6).The initial result was 1029 ng/dl.The sample was repeated by beckman methodology and the result was 752.75 ng/dl.On (b)(6) 2023, the reagent cassette was exchanged and the assay recalibrated.The sample was repeated with a result of 1024 ng/dl.The questionable result was reported outside of the laboratory and the clinician questioned the results.It was not known which result was believed correct.
Additional Manufacturer Narrative
Sample from the patient was submitted for investigation.H3: na.
Additional Manufacturer Narrative
The investigation testing of the patient sample confirmed the customer's results.No interference was found.The specific root cause could not be determined.

• Brand Name: ELECSYS TESTOSTERONE II
• Common Device Name: RADIOIMMUNOASSAY, TESTOSTERONE
• 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: 16932111
• Report Number: 1823260-2023-01639
• Device Sequence Number: 12493872
• Product Code: CDZ
• UDI-Device Identifier: 04015630939817
• UDI-Public: 04015630939817
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093421
• 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
• Report Date (Section B): 07/17/2023

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: 08/31/2023
• Device Catalogue Number: 07027915190
• Device Lot Number: 62093101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 07/17/2023
• 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 Age: 73 YR
• Patient Sex: Male