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

Catalog Number ASKU

Device Problem High Test Results (2457)

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

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).Expiration date was provided as (b)(6) 2019.

Event Description

The customer stated that they received erroneous results for one patient sample tested for elecsys ft3 iii (ft3), the elecsys ft4 ii assay (ft4 ii), and the elecsys ft4 iii assay (ft4 iii) on two cobas e 411 immunoassay analyzer (e411) systems.The erroneous results were reported outside of the laboratory.The physician asked for an investigation of the issue since there was an imbalance in the thyroid assay results.Please refer to the medwatches with the following.Patient identifiers for information related to each affected assays: (b)(6).Refer to the attachment for all patient sample data.The sample (dated (b)(6) 2018) was tested on the customer's e411 analyzer on (b)(6) 2018.The sample was provided for investigation where it was repeated on a second e411 system on (b)(6) 2018.The sample was also repeated on an architect system.No adverse events were alleged to have occurred with the patient.The serial number of the e411 analyzer used at the customer site was asked for, but not provided.The serial number of the e411 analyzer used for investigation was (b)(4).All ft4 iii values were above the normal reference ranges of the respective assays.All values generated by roche analyzers and abbott analyzers agree with each other with respect to the normal reference ranges of the assays.Calibration and control recovery on the e411 analyzer used for investigation were ok.For the observed result differences in ft4 iii values between the analyzers from roche and abbott, assays from different vendors can generate different values.This is related to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.Based upon analysis of the provided data, a general reagent issue can most likely be excluded.

• Brand Name: ELECSYS FT4 III ASSAY
• 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: 7484331
• MDR Text Key: 107983755
• Report Number: 1823260-2018-01359
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131244
• 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
• Report Date: 05/03/2018

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: ASKU
• Device Lot Number: 304692
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/03/2018
• 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: 62 YR