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

Catalog Number 06437281190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer stated that they received questionable thyroid test results for samples from two different patients.Data was provided for 3 samples from the first patient.Two samples, dated (b)(6) 2017, had erroneous results reported outside of the laboratory for elecsys ft3 iii (ft3) and the elecsys ft4 ii assay.The sample from (b)(6) 2017 also had an erroneous result for the elecsys tsh assay (tsh) that was reported outside of the laboratory.All results were reported outside of the laboratory from each of these two samples accompanied by a comment indicating there was a result discrepancy.This medwatch will refer to the ft4 assay.Patient identifier (b)(6) for information related to the ft3 assay.Patient identifier (b)(6) for information related to the tsh assay.Refer to the attachment for all patient data.The sample from (b)(6) 2017 was tested on two different cobas 8000 e 602 module (e602) analyzers at the customer site.The sample from (b)(6) 2017 was tested on one of the e602 analyzers at the customer site, an unknown roche elecsys analyzer at a second site, and a roche diagnostics elecsys e170 modular analytics immunoassay analyzer (e170) at a third site.Both samples were repeated on an abbott analyzer.For children under 16 years of age, the customer initially runs ft4 testing.When ft4 is elevated, the customer will then run ft3.Results from the (b)(6) 2017 were phoned to a general practitioner as the biochemist suspected that the tsh result was incorrect and that the patient was hyperthyroid.The patient was started on carbimazole and propranolol treatment around (b)(6) 2017 as some symptoms may have been attributed to hyperthyroidism.Once the abbott results were available, the general practitioner was contacted again.The patient's endocrinologist was also contacted since the patient was referred to the endocrinologist based on "tft" results.The endocrinologist stopped carbimazole and propranolol treatment after a review in the clinic on (b)(6) 2017.The patient was clinically euthyroid with no goiter, tshr antibodies were negative, and tpo was positive.The patient actually had neurological symptoms with episodes of feeling pale and blank.The patient was referred to another pediatrician based on the neurological symptoms.A request was made by the endocrinologist for a thyroid ultrasound of the patient, but this has not yet been performed.At the third site, the sample from (b)(6) 2017 was checked for interferences.No interferences caused by heterophilic antibodies to the roche assays were found.Tsh showed no evidence of interference on sample dilution.There was no evidence of analytical interference by "fdh", t4 antibodies, or t3 antibodies.No adverse events were alleged to have occurred with the patient.A serial number of (b)(4) was provided for the e602 #1 analyzer used at the customer site.The serial numbers of the other involved roche analyzers were asked for, but not provided.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.Samples from the patients were requested for investigation, but could not be provided.No further investigation was possible.A general reagent issue can most likely be excluded.It could be possible that an interfering factor is present in the patient samples that either affects the ft4 and ft3 assays from abbott or the ft4 and ft3 assays from roche diagnostics.

• 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: 6463220
• MDR Text Key: 72179397
• Report Number: 1823260-2017-00721
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• 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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2017
• 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
• Treatment: CARBIMAZOLE; PROPANALOL
• Patient Age: 11 YR
• Patient Weight: 40