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 04/15/2014

Event Type  malfunction  

Event Description

The customer reported discrepant beta human chorionic gonadotrophin (bhcg) result, for one patient, involving the access® total bhcg assay used in conjunction with the unicel® dxi 600 access® immunoassay system.The original result was above the normal reference range and was not released from the laboratory.There was no patient impact associated with this event.Subsequent testing of the patient's sample, on the same instrument, recovered lower bhcg results, within the normal reference range.Per laboratory protocol, bhcg results that are less than (<) 5 miu/ml are interpreted as negative.And patient samples with results less than (<) 50 miu/ml are reanalyzed.The customer stated the serum sample was clear in appearance and 24 hours old, following collection.No sample integrity issues were noted.The customer indicated quality control (qc) and system check were within specifications prior to and at the time of the event.

Manufacturer Narrative

There is no indication that the access® total bhcg 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® 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: 3801242
• MDR Text Key: 4479361
• Report Number: 2122870-2014-00335
• 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: 04/15/2014

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: 11/30/2014
• Device Catalogue Number: 33500
• Device Lot Number: 332734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2014
• Initial Date FDA Received: 05/08/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2013
• 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