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

Catalog Number 33880

Device Problem False Negative Result (1225)

Patient Problem No Code Available (3191)

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

The customer did not supply patient demographics such as date of birth or weight.(b)(6).A beckman coulter (bec) field service engineer (fse) was not dispatched to the customer's site.No hardware errors, flags or other assay issues were reported in conjunction with this event.There is no evidence that the access free t4 reagent was returned for evaluation.Two samples were sent to the beckman coulter complaint handling unit.The patient samples were analyzed on the access 2 immunoassay system serial number (b)(4), and recovered with access free t4 results below the analytical sensitivity of the assay.These results confirmed the results obtained by the customer.Interference testing, using a mix of different blockers, was performed on one of the sample.The blockers used in the interference testing consist of pool 1 (polymak 33, hbr-1) and pool 2 (goat, mouse, rabbit and bovine iggs) which are composed of animal derived antibodies.The sample recovered similarly and below the assay reference range when tested with the pool 1 of blockers.The result of the interference testing using pool 2 of animal derived antibodies significantly reduced the signal response and therefore increased the access free t4 result.Per the access free t4 instructions for use (ifu) limitations of procedure: "for assays employing antibodies, the possibility exists for interference by heterophile antibodies in the patient sample.Patients who have been regularly exposed to animals or have received immunotherapy or diagnostic procedures utilizing immunoglobulins or immunoglobulin fragments may produce antibodies, e.G.Hama, that interfere with immunoassays.Additionally, other heterophile antibodies such as human anti-goat antibodies may be present in patient samples." in conclusion, the investigation demonstrated that heterophile interference, which is listed in the access free t4 limitations of procedure, is the cause of the false low free t4 results.

Event Description

The customer reported obtaining reproducible low free thyroxine (access free t4) result for one (1) patient involving the laboratory's unicel dxi 800 immunoassay systems (serial number (b)(4)).The customer could not provide information on which of the three analyzers were in use for this event.Four (4) different sample from this same patient gave free thyroxine (access free t4) results below the assay's normal reference range.The reproducible low access free t4 results were released from the laboratory.The patient was treated based upon the access free t4 results.The patient has been treated with thyroxin and has received additional testing such as a thyroid ultrasound.No hardware errors, flags or other assay issues were reported in conjunction with this event.The patient's sample was collected in a serum tube and was centrifuged at 3,000g (g-force) for ten (10) minutes at room temperature.No issues with sample integrity were reported by the customer.

• Brand Name: ACCESS FREE T4
• 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 55318
• Manufacturer Contact: jeffrey koll ; 1000 lake hazeltine drive; chaska 55318
• MDR Report Key: 5409691
• MDR Text Key: 37432289
• Report Number: 2122870-2016-00070
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K982250
• 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
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 33880
• Device Lot Number: 530121
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2016
• Initial Date FDA Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/20/2015
• 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: 17 YR