MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TESTOSTERONE II ASSAY; TESTOSTERONE ASSAY

Catalog Number	08946370190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys testosterone ii results from one patient sample tested on the cobas e 801 analytical unit with serial number (b)(6).The initial result was not reported outside of the laboratory.On (b)(6) 2023, the initial result using the primary tube was 1500 ng/dl with a data flag.The reporter then diluted the patient sample to 1:5.It is not clear if the final result of this dilution is 435 ng/dl.Or 500 ng/dl.On (b)(6) 2023, it is not clear if the result of 87.8 ng/dl was a repeat result.Another repeat result using the primary tube was 587 ng/dl.
Additional Manufacturer Narrative
On 26-may-2023, the customer reported a new questionable testosterone result.The initial result was not reported outside of the laboratory.On (b)(6) 2023, the initial result of the undiluted sample was >1500 ng/dl with a data flag.On (b)(6) 2023, the patient sample was diluted at 1:5.The first repeat result using the diluted sample was 7.90 ng/dl.This result was multiplied by the dilution factor of 5 and the result was 39.5 ng/dl.The final dilution result was 40 ng/dl.On (b)(6) 2023, the patient sample was rerun because the dilution result was normal.The second repeat result using the primary tube was 32.1 ng/dl.The third repeat result using the primary tube was 33.4 ng/dl medwatch field b7 was updated.The calibration on (b)(6) 2023 was within specifications.The initial calibration on the same day had a failed result.The qc was within specifications.One reagent rack pack was not quality controlled.The alarm trace could not be translated.The precision check on (b)(6) 2023 was within specifications.A general reagent problem can be excluded because the provided quality validation was within expectations.The investigation did not identify a product problem.The cause of the event could not be determined. .

• Brand Name: ELECSYS TESTOSTERONE II ASSAY
• Common Device Name: TESTOSTERONE ASSAY
• 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: 16919273
• Report Number: 1823260-2023-01605
• Device Sequence Number: 6910781
• Product Code: CDZ
• UDI-Device Identifier: 07613336170571
• UDI-Public: 07613336170571
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K211685
• 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): 06/02/2023

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: 08946370190
• Device Lot Number: 620937
• 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: 04/13/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 06/02/2023
• 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: 51 YR
• Patient Sex: Male