MAUDE Adverse Event Report: BECKMAN COULTER ACCESS THYROGLOBULIN ANTIBODY II REAGENT; IMMUNOCHEMICAL, THYROGLOBULIN AUTOANTIBODY

Catalog Number A32898

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 06/16/2015

Event Type  malfunction  

Manufacturer Narrative

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 thyroglobulin antibody ii reagent was returned for evaluation.The customer sent the patient's sample to beckman coulter where testing was performed to evaluate the sample for interference.No interference was found.The sample was also was analyzed on a second methodology ((b)(4)) and recovered with a result above the assay's normal reference range.In conclusion, the cause of the event cannot be determined with the available information.

Event Description

The customer reported obtaining a normal thyroglobulin antibody (access thyroglobulin antibody ii) result for one (1) patient on the unicel dxi 800 access immunoassay system (serial number (b)(4)) that was discordant to another methodology.The initial access thyroglobulin antibody ii result was within the normal reference range of the assay.The customer analyzed the patient's sample on an alternate methodology ((b)(4)) and obtained a discordant, higher result above the assay's normal reference range.The access thyroglobulin antibody ii result was not reported outside the laboratory.There was no report of patient injury or change in patient treatment associated with this event.Beckman coulter (bec) cf originator recommended that the customer provide the patient sample for testing by the bec complaint handling unit (chu).Calibration, qc (quality control) and system check parameters were all recovering within expected ranges at the time of the event.Information on the collection and centrifugation of the patient sample was not supplied.There was no report of sample integrity issues reported by the customer.

• Brand Name: ACCESS THYROGLOBULIN ANTIBODY II REAGENT
• Type of Device: IMMUNOCHEMICAL, THYROGLOBULIN AUTOANTIBODY
• 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: 4953539
• MDR Text Key: 23447464
• Report Number: 2122870-2015-00458
• Device Sequence Number: 1
• Product Code: JNL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K062516
• 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
• Report Date: 07/02/2015

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: 02/28/2016
• Device Catalogue Number: A32898
• Device Lot Number: 438550
• Was Device Available for Evaluation?: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA 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 Age: 51 YR