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

Catalog Number 06437281190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable elecsys ft4 ii assay results for three patient samples from cobas 8000 core unit 16u5-06.Patient 1: initial result was 3.13 ng/dl.The repeat results from other analyzers on (b)(6) 2018 were 1.58 ng/dl and 1.59 ng/dl.Patient 2: initial result was 2.75 ng/dl.The repeat results from other analyzers on (b)(6) 2018 were 1.41 ng/dl and 1.44 ng/dl.This patient was a (b)(6) male.Patient 3: initial result was 3.17 ng/dl.The repeat results from other analyzers on (b)(6) 2018 were 1.48 ng/dl and 1.44 ng/dl.This patient was a (b)(6) male.No erroneous result was reported outside of the laboratory.There was no allegation of an adverse event.

Manufacturer Narrative

The quality control data was not within the acceptable range on the day of the event.The calibration data was within acceptable range.The issue appeared to be resolved after maintenance was performed.The investigation was unable to find a definitive root cause.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• 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: 7725935
• MDR Text Key: 115538218
• Report Number: 1823260-2018-02259
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 04015630930920
• UDI-Public: 4015630930920
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K961489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06437281190
• Device Lot Number: 288197
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2018
• 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: 9 YR