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

Catalog Number 07027915190

Device Problems Incorrect Measurement (1383); High Test Results (2457)

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

Event Date 04/18/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Sample from the patient was submitted for investigation.H3: na.

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
• Type of Device: 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
• MDR Text Key: 315223648
• Report Number: 1823260-2023-01639
• Device Sequence Number: 1
• Product Code: CDZ
• UDI-Device Identifier: 04015630939817
• UDI-Public: 04015630939817
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093421
• 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: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• 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: 07027915190
• Device Lot Number: 62093101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• 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: 73 YR
• Patient Sex: Male