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

Catalog Number 05200067160

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

The customer received a complaint from a clinician about a questionable high elecsys testosterone ii assay result for one patient.The type of roche analyzer used by the customer was not provided.Serial numbers (b)(4) were provided.Clarification was requested but was not provided.The initial result was >52.0 nmol/l.When the clinician sent a different sample from the patient to a commercial laboratory using a siemens analyzer, the result for testosterone was normal.No specific data was provided.There was no allegation of an adverse event.Analyzer performance testing was done.

Manufacturer Narrative

Clarification was received that the analyzer involved was cobas 8000 e 602 module serial number was (b)(4).

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.Possible causes for the difference in the results include a possible sample mix up or contamination.The calibration and qc data provided showed no issues and verified the reagent performance was okay.

• Brand Name: ELECSYS TESTOSTERONE II ASSAY
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6521750
• MDR Text Key: 73805403
• Report Number: 1823260-2017-00890
• Device Sequence Number: 1
• Product Code: CDZ
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K093421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05200067160
• Device Lot Number: 19105300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR