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

Catalog Number	07027915190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calibration and qc data were acceptable.Further information regarding the event was requested but not provided.No case-specific root cause could be found.The product meets specifications.The investigation did not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
The initial reporter received a questionable elecsys testosterone ii assay result for one patient sample with the cobas e 801 module serial number (b)(4).The initial result was >15 ng/ml.The customer decided to repeat testing due to the result not matching the patient¿s clinical picture.The sample was repeated at another laboratory on a roche elecsys with a result of 7.5 ng/ml.It is unknown if the questionable result was reported outside of the laboratory.

• Brand Name: ELECSYS TESTOSTERONE II ASSAY
• Common Device Name: RADIOIMMUNOASSAY, TESTOSTERONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12308181
• Report Number: 1823260-2021-02339
• Device Sequence Number: 3682273
• Product Code: CDZ
• UDI-Device Identifier: 04015630939817
• UDI-Public: 04015630939817
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2021

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: 04/30/2022
• Device Catalogue Number: 07027915190
• Device Lot Number: 520961
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1