MAUDE Adverse Event Report: BECKMAN COULTER ACCESS HYPERSENSITIVE HTSH; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Catalog Number 33820

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

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

Event Date 08/12/2014

Event Type  malfunction  

Event Description

The customer reported discrepant thyroid-stimulating hormone (tsh) results, for one patient, involving the access hypersensitive htsh assay used in conjunction with the unicel dxi 600 access immunoassay system.The customer stated the original result was released out of the laboratory.There was no report of patient injury or change in patient treatment associated with this event.Subsequent testing of the patient's sample, on the same instrument, generated lower results.The patient's plasma sample was centrifuged at 2,700 rpm (rotations per minute) for ten minutes.The sample was approximately four and one half hours old.No sample integrity issues were noted.Data provided indicated quality control (qc), system check, and precision test passed within specifications.No system issues were reported.The instrument was in normal operation.

Manufacturer Narrative

There is no indication that the access hypersensitive htsh device was returned for evaluation.Service was not dispatched as the customer did not question system performance.In conclusion, a definitive cause of the incident could not be determined with the available information.

• Brand Name: ACCESS HYPERSENSITIVE HTSH
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER IRELAND; mervue business park; galway, ; EI
• Manufacturer Contact: dung nguyen ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149614941
• MDR Report Key: 4070065
• MDR Text Key: 4852699
• Report Number: 8020879-2014-00008
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/12/2014

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: 04/30/2015
• Device Catalogue Number: 33820
• Device Lot Number: 424385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2014
• Initial Date FDA Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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