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

Catalog Number 05200067190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

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

Event Date 09/05/2022

Event Type  malfunction  

Manufacturer Narrative

A sample from the patient was requested for investigation, but the remaining volume was insufficient.The investigation could not identify a product problem.The cause of the event could not be determined.Per product labeling: "implausible elevated testosterone values in women should be verified by an extraction method or a validated lc-ms/ms tandem method.".

Event Description

The initial reporter stated they received questionable results for one patient sample tested with elecsys testosterone ii on a cobas 6000 e 601 module (serial number (b)(4)) and on a cobas 8000 e 801 module (serial number unknown) when compared to a result from the abbott method.The sample results were reported outside of the laboratory.Two sample tubes were collected from the patient at the same time, tube a and tube b.Tube a was tested on the e 601 analyzer twice, resulting in testosterone values of 10.06 nmol/l and 10.23 nmol/l.This tube was also repeated on an e 801 analyzer at a second site, resulting in a value of 9.85 nmol/l.Tube b was tested on the e 601 analyzer, resulting in a testosterone value of 10.23 nmol/l.This sample was repeated on an abbott analyzer at a third site, resulting in a value of 1.25 nmol/l.The testosterone reagent lot number used on the e 601 analyzer is 620734, with an expiration date of 31-jul-2023.The reagent lot number and expiration date used on the e 801 analyzer were requested, but not provided.

• 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: 15496442
• MDR Text Key: 306407228
• Report Number: 1823260-2022-02959
• Device Sequence Number: 1
• Product Code: CDZ
• 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
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 05200067190
• Device Lot Number: 620734, ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2022
• 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: 34 YR
• Patient Sex: Female