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

Catalog Number 06437281190

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of erroneous results for 1 patient sample tested for free thyroxine (ft4 ii).The erroneous result was reported outside of the laboratory.The initial ft4 ii result from the e602 analyzer was 0.68 ng/dl.The patient also had a tsh result at this time of 6.20 mu/l.Both results were reported outside of the laboratory.An aliquot was made from the primary tube and the sample was repeated on an abbott architect instrument and the ft4 result was 1.16 ng/dl.No adverse event occurred.The e602 analyzer serial number was (b)(4).

Manufacturer Narrative

Quality controls were acceptable.Based on the available data, a general reagent issue can most likely be excluded.A pre-analytical issue cannot be excluded.

Manufacturer Narrative

The sample was submitted for investigation.The ft4 values generated at the customer site could not be confirmed with the measurements received during the investigation.The ft4 values were in the normal reference range.No reagent specific issue could be identified in the investigated sample.Upon visual inspection of the sample, no clots or fibrin filaments were detected.It was recommended to check the pre-analytic procedure at the customer site.

• 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: 5221080
• MDR Text Key: 31077977
• Report Number: 1823260-2015-04533
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 12/29/2015

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 Catalogue Number: 06437281190
• Device Lot Number: 183473
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 10/22/2015
• Initial Date FDA Received: 11/12/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/17/2015; 12/29/2015
• 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
• Patient Age: 072 YR