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 10/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The customer questioned thyroid results that did not match the clinical condition for 1 patient and submitted the sample for investigation.Based on the data provided, the customer¿s elecsys ft4 ii assay (ft4 ii) results were erroneous when compared to an unspecified clia method.The erroneous result at the customer site was reported outside of the laboratory where it was questioned by the physician.The customer¿s results were reproduced at the investigation site.There was no allegation that an adverse event occurred.The instrument type and serial number used at the customer site was not provided.The type of instrument used for the clia method was not provided.The instrument used at the investigation site was not provided.

Manufacturer Narrative

The customer was using a cobas e 411 immunoassay analyzer.The clia method analyzer was a siemens centaur.A specific root cause was not identified.Additional information was requested for investigation but was not provided.Based on the information available, a general reagent issue can most likely be excluded.All ft4 results (customer site, siemens centaur and investigation site) corresponded clinically.All results were above the reference range for the assays.Assays from different manufacturers can produce different results.This relates to the overall set up of the assays, the antibodies used and differences in reference materials/methods and the standardization methodology used.

• 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: 7075353
• MDR Text Key: 94302779
• Report Number: 1823260-2017-02808
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

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: 11/13/2017
• Initial Date FDA Received: 12/01/2017
• Supplement Dates Manufacturer Received: 11/13/2017
• Supplement Dates FDA Received: 12/08/2017
• 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
• Patient Age: 22 YR