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

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 05/09/2015

Event Type  malfunction  

Event Description

The customer reported obtaining a human thyroid-stimulating hormone ( access hypersensitive htsh) result within the normal reference range for one patient sample on the laboratory's unicel dxi 600 access immunoassay system (serial number (b)(4)) that was discordant to another methodology.The initial access hypersensitive htsh result was reported outside the laboratory and was questioned by the physician as it did not match the clinical picture of the patient.The customer sent the same patient's sample to a reference laboratory for analysis on another methodology (methodology not supplied) and obtained a higher result, within the customer's expectations.There was no report of patient injury or change in patient treatment associated with this event.Assay calibration, quality control (qc) and system checks were performing within published specifications.The patient's sample was collected in a serum tube and centrifuged at 1.2 relative centrifugal force (rcf) for ten minutes.The customer noted no sample integrity issues.

Manufacturer Narrative

The customer did not supply patient demographics such as age, date of birth, sex or weight service was not dispatched.There is no evidence of pre-analytical sample handling issue and no indication that the access htsh reagent was returned for evaluation.In conclusion, the cause of the event cannot be determined with the available information.

• Brand Name: ACCESS HYPERSENSITIVE HTSH REAGENT
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE, PRODUCT CODE: JLW
• 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, MN 55318 ; 9523681361
• MDR Report Key: 4899644
• MDR Text Key: 6536926
• Report Number: 2122870-2015-00416
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K042281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/12/2015

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: 12/31/2015
• Device Catalogue Number: 33820
• Device Lot Number: 436910
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2015
• Initial Date FDA Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2015
• 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