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 12/12/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for one patient sample tested for the elecsys tsh assay (tsh), elecsys ft3 iii (ft3), and the elecsys ft4 ii assay (ft4) on a cobas 8000 e 602 module (e602).The erroneous results were reported outside of the laboratory.The patient's physician asked for the sample to be re-measured and stated that a previous sample of the patient was confirmed to have non-specific reactions to the mentioned roche assays.This medwatch will apply to the ft4 assay.Patient identifier (b)(6) for information related to the tsh assay.Patient identifier (b)(6) for information related to the ft3 assay refer to the attachment for all patient data.The sample was initially tested at the customer site on the e602 analyzer on (b)(6) 2017.The sample was provided for investigation, where it was tested on a cobas 6000 e 601 module (e601) on (b)(6) 2017.The sample was also repeated on a centaur analyzer.No adverse events were alleged to have occurred with the patient.The e602 analyzer used at the customer site was serial number (b)(4).The e601 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 265631, with an expiration date of september 2018 was used on this analyzer.

Manufacturer Narrative

A previous sample from the patient was provided for investigation.Investigations of this sample determined that it contained a factor which interferes with a component of the ft4 assay.This limitation is covered in product labeling.The complained sample from the patient was provided for investigation.The roche ft4 value was lower than values generated at the customer site and during initial investigations.This difference is most likely due to transport and storage conditions between the measurements performed at the customer site and during initial and latter investigations.The same ft4 interfering factor was identified in this sample.

• 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: 7177835
• MDR Text Key: 97722770
• Report Number: 1823260-2018-00097
• 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
• Report Date: 02/16/2018

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: 12/26/2017
• Initial Date FDA Received: 01/10/2018
• Supplement Dates Manufacturer Received: 12/26/2017
• Supplement Dates FDA Received: 02/16/2018
• 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: 30 YR