MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 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 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of erroneous high results for 10 patient samples tested for elecsys tsh assay (tsh) on a cobas 6000 e 601 module.Based on the data provided, erroneous elecsys ft4 assay (ft4) and elecsys ft4 ii assay (ft4 ii) results were also identified.The erroneous results were reported outside of the laboratory.This medwatch will cover ft4.(b)(4).Refer to the attached data for patient results.When the initial high results were received the samples were repeated on the e601 module again and the results were reproducible.Qc results were also good.The high results were not considered to be correct based on the clinical picture and historical results for each patient.The samples were sent to an external laboratory using the abbott architect method and the results were lower than the results from the e601 module.There is no information to reasonably suggest any patients were adversely affected.The e601 module serial number was not provided.

Manufacturer Narrative

Normal reference ranges for the assays involved are calculated mainly from a caucasian population.Geographical differences may exist.Laboratories can determine their own reference ranges in accordance with applicable guidelines.Based on additional data provided from the customer, a new reference range was calculated for the tsh assay for the population from this customer site.Based on this new reference range, the customer's tsh results are within this normal reference range.Based on the additional data provided by the customer, the customer's ft4 results are well within the normal reference range in product labeling.Based on the information available, a general reagent issue can be excluded.The investigation was unable to find a definitive root cause.

• Brand Name: ELECSYS FT4 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: 7244840
• MDR Text Key: 99787410
• Report Number: 1823260-2018-00348
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• 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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2018
• 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