MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TESTOSTERONE G2; RADIOIMMUNOASSAY, TESTOSTERONE

Catalog Number 05200067190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of erroneous results for two patients tested for testosterone ii from cobas e601 with the serial number (b)(4).The first patient's o was tested on (b)(6) 2016.The original result was 1158 ng/dl on the cobas e601 module (serial number (b)(4)).The sample was sent to a second laboratory and tested by clia.The result was 660 ng/dl.The second patient was male and (b)(46 years old.He was tested on (b)(6) 2016.The testosterone result was 1265 ng/dl and the sample was sent to a second laboratory.That result by clia was 539 ng/dl.The erroneous results were reported outside of the laboratory.There was no adverse event.The patient samples were requested for investigation.

Manufacturer Narrative

The volume of the samples returned for investigation was insufficient and could not be investigated.The calibration and qc data provided for investigation were within specifications.Performance testing of the analyzer indicated the instrument was performing to specifications.A specific root cause for the event could not be determined.

• Brand Name: TESTOSTERONE G2
• 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: 5567195
• MDR Text Key: 42383667
• Report Number: 1823260-2016-00423
• Device Sequence Number: 1
• Product Code: CDZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05200067190
• Device Lot Number: 187861
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2016
• 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