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

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of erroneous results for 1 patient tested for thyrotropin (tsh).Based on the data provided, erroneous free thyroxine (ft4) were also identified.The erroneous results were reported outside of the laboratory.The tsh comparison testing was being performed between an e602 analyzer and a beckman unicel instrument.The ft4 comparison results were from an e 601 analyzer and the beckman unicel instrument.This medwatch will cover ft4.Refer to medwatch with (b)(6) for information on the tsh erroneous results.The initial tsh result from the e 602 analyzer was 4.79 mui/l.The result did not correspond to the patient's clinical status of hyperthyroidism.The repeat result from the beckman unicel instrument was <0.015 uui/ml.This result was believed to be correct based on the clinical status of the patient.The initial ft4 result from the e 601 analyzer was 20.78 ng/l.The repeat result from the beckman unicel instrument was 15.4 pg/ml.The customer also alleged that the tsh results from the e602 analyzer were erroneously high for over 3 years.The patient was diagnosed with hyperthyroidism based on these results and was being treated with l- thyroxine.No adverse event due to this treatment has occurred.The e 602 analyzer serial number (b)(4).The e 601 analyzer serial number was (b)(4).

Manufacturer Narrative

Samples from the patient were submitted for investigation.The ft4 values during the investigation were also elevated.No interfering factor was identified.

• 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) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5233424
• MDR Text Key: 31529563
• Report Number: 1823260-2015-04576
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: ASKU
• 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: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: ASKU
• Device Lot Number: 186893
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 11/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2015
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 067 YR