MAUDE Adverse Event Report: BECKMAN COULTER ACCESS TOTAL BHCG; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Catalog Number 33500

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 04/20/2014

Event Type  malfunction  

Event Description

The customer reported a non-reproducible total-beta human chorionic gonadotropin (tbhcg) result on an access 2 immunoassay system for one patient.Tbhcg had been calibrated with tbhcg calibrator lot number 325475.After an initial tbhcg result was obtained, the sample was repeated on the same instrument per laboratory protocol and the repeat result was much higher.The high result was inconsistent with the other tests in the panel.All tests for the patient sample were repeated on the same instrument; results were consistent with initial results.The discrepant result was not reported outside of the laboratory.Quality control (qc) results were within range for all assays prior to this event.Recent system checks and calibration were passing.There were no issues with sample processing, collection, or integrity.

Manufacturer Narrative

The customer sent archive data file to bec customer technical specialist; analysis of data does not indicate a systemic issue.Hardware issues were not found and cause of this event is not known.A bec field service engineer (fse) was not dispatched.

• Brand Name: ACCESS TOTAL BHCG
• Type of Device: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: dung nguyen ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149614941
• MDR Report Key: 3822289
• MDR Text Key: 4399714
• Report Number: 2122870-2014-00346
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023480
• 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: 04/23/2014

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: 12/31/2014
• Device Catalogue Number: 33500
• Device Lot Number: 336174
• Other Device ID Number: SW VERSION 3.3.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2014
• Initial Date FDA Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2014
• 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