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

Catalog Number 06437281190

Device Problem High Test Results (2457)

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

Event Date 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

The customer received questionable elecsys ft4 ii assay and elecsys ft3 iii results for multiple samples for one patient.On (b)(6) 2017, the patient had been diagnosed as hyperthyroid.After being treated for a while, the endocrinologist noticed the ft3 and ft4 results were high even though the tsh results and clinical symptoms appeared to be back to normal.The doctor suspected a t3 autoantibody, t4 autoantibody, or another interference that impacted the results.Refer to the attachment to the medwatch for all patient data.There was no allegation of an adverse event.The customer used a cobas 8000 e 602 module.The serial number was requested but was not provided.(b)(4).

Manufacturer Narrative

Two samples from the patient were submitted for investigation.((b)(6) 2017 and (b)(6) 2017) the results for the sample taken on (b)(6) 2017 generated by the customer were: tsh = 0.066 uiu/ml.Ft3 = 7.33 pg/ml.Ft4 = 2.2 ng/dl.Investigation of the provided samples found an interfering factor to a component of the reagent in the sample.This most likely caused the high ft4 and ft3 results.The rarely occurring event of identified interfering factor is documented in product labeling for the assays.Therefore no product problem could be found.The incidence rate of the identified interfering factor is monitored on a quarterly basis.

• 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: 6845719
• MDR Text Key: 85016546
• Report Number: 1823260-2017-01908
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2017

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: Health Professional
• Device Catalogue Number: 06437281190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2017
• Initial Date FDA Received: 09/06/2017
• Supplement Dates Manufacturer Received: 08/18/2017
• Supplement Dates FDA Received: 11/06/2017
• 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
• Patient Age: 30 YR