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

Catalog Number 06437281190

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 08/07/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer initially complained of bad quality control results on a newly delivered reagent pack for free thyroxine (ft4) and had performed calibration 3 times.All attempts produced unacceptable results.The customer was advised to perform calibration again on a new reagent pack from the same lot and repeat the patient sample that had already been measured.After the repeat testing was performed, erroneous results were identified for 1 patient sample tested for ft4.Both the initial and the repeat results were reported outside of the laboratory.The initial ft4 result was 1.12 ng/dl.On (b)(6) 2015, the repeat result was 1.42 ng/dl.No adverse event was reported.The e411 analyzer serial number was not provided.On (b)(6) 2015, a sales representative visited the customer site.The sales representative identified clumped magnetic particles in the reagent.

Manufacturer Narrative

The reagent pack with lot 184927031 was returned for investigation.The initial observation of clumped magnetic particles could not be confirmed.During the invesigation, it was observed that the customer's calibration signals from the day of the event were not acceptable.The calibration signals from (b)(6) 2015 were also not acceptable (assuming the same reagent pack of 184927031 was used).The calibration results from the 2nd run on (b)(6) 2015 were acceptable the root cause of the bad calibration signals most likely relates to the specific reagent pack that was used for these measurements.The root cause of the clumped magnetic particles may have been caused by improper storage or an incorrect reagent incubation time in letting the reagent come to room temperature.Based on the available information, a general reagent issue can mostly likely be excluded.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5094499
• MDR Text Key: 26476382
• Report Number: 1823260-2015-04204
• 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
• Report Date: 10/13/2015

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 Expiration Date: 03/30/2016
• Device Catalogue Number: 06437281190
• Device Lot Number: 184927031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2015
• 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