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 10/17/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for four patient samples tested for elecsys ft3 iii (ft3) and the elecsys ft4 ii assay (ft4) on a cobas 8000 e 602 module (e602).It was asked, but it is not known if the erroneous results were reported outside of the laboratory.This medwatch will apply to the ft4 assay.Please refer to the medwatch with patient identifier (b)(4) for information related to the ft3 assay.Refer to the attachment for all patient data.The erroneous result data is highlighted in yellow.Samples were initially tested on the customer's e602 analyzer.The samples were then provided for investigation, where they were tested on a cobas 6000 e 601 module (e601) and a cobas e 411 immunoassay analyzer (e411).No adverse events were alleged to have occurred with the patients.The e601 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number of 265631, with an expiration date of 01-sep-2018 was used on this analyzer.The e411 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number of 265631, with an expiration date of 01-sep-2018 was used on this analyzer.

Manufacturer Narrative

The customer provided samples 171004-419, 171011-920, and 171011-1276 for investigation.There was no remaining sample volume available for sample 171012-445, so no further investigation of this sample was possible.Samples 171004-419 and 171011-1276 were found to contain an interfering factor to a component of the ft3 and ft4 assays.This limitation is covered in product labeling.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings.

Manufacturer Narrative

The patient with sample id (b)(6) had the following test results on (b)(6) 2018: tsh = 1.64 uiu/ml, ft4 = 1.59 ng/dl, ft3 = 6.00 pg/ml, anti-tshr = 14.10 iu/ml.

• 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: 7024802
• MDR Text Key: 92862336
• Report Number: 1823260-2017-02596
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• 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: 10/25/2017
• 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