MAUDE Adverse Event Report: BECKMAN COULTER ACCESS THYROGLOBULIN REAGENT; SYSTEM,TEST,THYROGLOBULIN

Catalog Number 33860

Device Problems High Test Results (2457); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Misdiagnosis (2159); No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2015

Event Type  Injury  

Event Description

The customer reported obtaining reproducible elevated thyroglobulin (access thyroglobulin) results for one (1) patient involving the laboratory's unicel dxi 800 access immunoassay system (serial number (b)(4)).The elevated access thyroglobulin results were discordant with the roche thyroglobulin result which was negative.Customer reported that the elevated thyroglobulin results were discordant with the patient clinical picture.The thyroid antibody (access thyroglobulin antibody ii) assay result for this patient was negative.The initial, elevated access thyroglobulin result was released from the laboratory.There was a report of a change in patient treatment associated with this event as the patient received radiology and nuclear medicine tests.System checks, quality controls (qc) and calibrations were performing within specifications at the time of the event.The patient's initial sample was collected in a seven (7) ml tube.The customer stated that the sample was centrifuged for ten (10) minutes at 3,500 rpm (revolutions per minute), at 32°c (celsius degree).There were no issues related to sample integrity reported by the customer.

Manufacturer Narrative

Pt gender and weight: the customer did not supply patient's date of birth or weight.Initial reporter: customer account telephone number is (b)(6).\a beckman coulter (bec) field service engineer (fse) was not dispatched for this event.There is no evidence that the access thyroglobulin reagent was returned for evaluation.In conclusion, the cause of the event cannot be determined with the available information.

Manufacturer Narrative

The customer provided one sample for interference testing by the beckman coulter (bec) complaint handling unit (chu).The patient sample was analyzed on the access 2 immunoassay system serial number (b)(4), and recovered with an access thyroglobulin result of 72.07 ng/ml.This result confirmed the result obtained by the customer.The access thyroglobulin normal reference range is 1.15 - 50.3 ng/ml.Interference testing, using a mix of different blockers, was performed.The blockers used in the interference testing consist of pool 1 (polymak 33, hbr-1) which is composed of animal derived antibodies and scavenger alp, a blocker related to alkaline phosphatase.The sample recovered above the assay reference range when tested with the scavenger alp with result of 75.75 ng/ml.The result of the interference testing using the pool 1 of animal derived antibodies significantly reduced the result to within the assay reference range as it recovered at 2.65 ng/ml.Per the thyroglobulin 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 thyroglobulin limitations of procedure, is the cause of the falsely elevated thyroglobulin result.

• Brand Name: ACCESS THYROGLOBULIN REAGENT
• Type of Device: SYSTEM,TEST,THYROGLOBULIN
• 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: 4906234
• MDR Text Key: 6836990
• Report Number: 2122870-2015-00426
• Device Sequence Number: 1
• Product Code: MSW
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K031269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 33860
• Device Lot Number: 430265
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2014
• 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: 74 YR