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

Catalog Number 08946370190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 315093199
• Report Number: 1823260-2023-01605
• Device Sequence Number: 1
• Product Code: CDZ
• UDI-Device Identifier: 07613336170571
• UDI-Public: 07613336170571
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K211685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male