MAUDE Adverse Event Report: BECKMAN COULTER ACCESS FREE T4 REAGENT; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number 33880

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/16/2015

Event Type  Injury  

Manufacturer Narrative

Qc, calibration, and precision run were performing with in assay and instrument specifications.The customer has received input from doctors indicating that the upper limit of their access free t4 reference range of 0.61 - 1.12 ng/dl is too low for their patient population.Per the access free t4 instructions for use, customers are instructed that "each laboratory should establish its own reference ranges to assure proper representation of specific populations." in conclusion, this event was caused by the access free t4 reference range established at the customer site.

Event Description

The customer reported obtaining a free thyroxine (access free t4) result above the normal reference range on the laboratory's unicel dxi 800 access immunoassay system (serial number (b)(4)) for one patient.The result was reported out of the laboratory.The thyroid stimulating hormone test result (1.35 uiu/ml) for this patient was within the normal range.There was a change in the patient's treatment as the patient was started on methimazole.The methimazole was discontinued as the doctor believed the patient was not hyperthyroid.Access free t4 calibrations and qc (quality control) were passing within assay specifications.The customer completed a 20-replicate precision run on each pipettor, which met assay and system specifications.The sample was collected in a becton dickinson serum separator tube and centrifuged for 10 minutes at 3000 rpm (revolutions per minute).There was no report of sample integrity issues reported by the customer.

• Brand Name: ACCESS FREE T4 REAGENT
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: jeffrey koll ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681361
• MDR Report Key: 5029434
• MDR Text Key: 24012150
• Report Number: 2122870-2015-00528
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 33880
• Device Lot Number: 522761
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 42