MAUDE Adverse Event Report: ROCHE DIAGNOSTICS FT4, FREE THYROXINE; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number 06437281160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2015

Event Type  malfunction  

Event Description

The customer reported that they received an erroneous result for one patient sample tested for free thyroxine (ft4).The customer initially reported that they were having issues with controls and calibrations.The customer stated that they were unable to get an acceptable calibration with one reagent pack and quality controls failed on a second reagent pack.The customer noted that an erroneous result from the one patient sample was released outside of the laboratory when they were having these reagent pack issues.The customer place a third reagent pack on board, calibrated it, and ran controls.Controls were acceptable on the third reagent pack.The affected sample was repeated after controls were found to be acceptable with the third reagent pack.The sample initially resulted as 2.14 ng/dl and this value was reported outside of the laboratory.The sample was repeated and resulted as 0.99 ng/dl.The repeat result was believed to be correct.The patient was not adversely affected.The sample was tested on e601 module analyzer serial number (b)(4).The field service representative was unable to duplicate the issue.He ran performance testing and this was within specifications.

Manufacturer Narrative

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

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.A general reagent issue can most likely be excluded.The erroneous ft4 value was most likely caused by a distorted or shifted calibration curve.The shift in the calibration curve was most likely caused by a reagent handling issue.An analyzer specific issue could not be excluded.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• 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: 4911771
• MDR Text Key: 20451034
• Report Number: 1823260-2015-03795
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961489
• 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: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 06437281160
• Device Lot Number: 18347401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 06/29/2015
• 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: 066 YR