MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E-ELECSYS TESTOSTERONE GEN.2; RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE

Catalog Number 05200067160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2014

Event Type  malfunction  

Event Description

The customer received a questionable testosterone result for one patient sample from the cobas e601 analyzer serial number (b)(4).Two specimens were drawn from the patient.The testosterone result from the first tube was 663.6 ng/dl.The repeat result was 237.2 ng/dl.The result from the second tube was 232.2 ng/dl.The result of 663.6 ng/dl was released outside the laboratory.The repeat result of 237.2 ng/dl was believed to be correct.There was no harm to the patient.The field service representative could not find a cause.He noted replacement of the reagent did not resolve the problem.He ran performance testing on the analyzer and performed extensive trouble shooting over several days which showed no problems.Several precision studies gave poor results and indicated reagent instability that could produce questionable results.

Manufacturer Narrative

It was unknown if the initial reporter sent report to the fda.

Manufacturer Narrative

The reagent lot in use at the time of event was 171423.The expiration date was requested, but was not provided.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.Review of the provided calibration and qc data did not indicate a general reagent issue.Instrument performance checks did not produce any concerns with performance of the analyzer.

• Brand Name: COBAS E-ELECSYS TESTOSTERONE GEN.2
• Type of Device: RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 3670539
• MDR Text Key: 4341341
• Report Number: 1823260-2014-01660
• Device Sequence Number: 1
• Product Code: CDZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Catalogue Number: 05200067160
• Device Lot Number: 171423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 02/13/2014
• 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: 057 YR