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 09/08/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for two patient samples tested for elecsys ft3 iii (ft3), the elecsys ft4 ii assay (ft4), and elecsys dhea-s (dhea-s) on a cobas 8000 e 602 module (e602).All results were higher when compared to results from competitor systems (liaison, abbott, and an unknown method).The customer believes that the sample contains an interferent to the roche assays.This medwatch will apply to the ft4 assay.Please refer to the medwatch with a1.Patient identifier (b)(4) for information related to the ft3 assay and refer to the medwatch with a1.Patient identifier (b)(4) for information related to the dhea-s assay.Refer to the attachment for all patient data.The first patient's erroneous results were reported outside of the laboratory and were considered to be implausible.Therefore, the first patient's sample was repeated using competitor methods.No adverse events were alleged to have occurred with the patients.Treatment decisions for both patients were made based on results from the competitor systems.The e602 analyzer serial number was asked for, but not provided.

Manufacturer Narrative

Samples from the two patients were provided for investigation.Investigations of the samples determined that they contain an interferent to the streptavidin used in the ft3, ft4, and dhea-s assays.This limitation is covered in product labeling.

• 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: 6901032
• MDR Text Key: 89481488
• Report Number: 1823260-2017-02138
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• 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: 09/11/2017
• 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