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

Catalog Number 33500

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2014

Event Type  malfunction  

Event Description

The affiliate stated the customer reported elevated total beta human chorionic gonadotrophin (tbhcg) results, for three patients, and elevated quality control (qc) involving the access total bhcg reagent used in conjunction with the unicel dxi 800 access immunoassay system.The customer calibrated a new reagent lot and noted it recovered within the established ranges - qc was also within specification.The customer indicated the elevated tbhcg patient results were not released out of the laboratory.There was no report of patient consequence or change in patient treatment associated with this event.Archive data review indicates that higher recovery does occur with the involved reagent lot across multiple reagent packs.The patients' samples were collected in 100x13 mm becton dickinson (bd) tubes and centrifuged at 3,000 rpm (rotations per minute) for ten minutes.The customer indicated the samples were analyzed approximately five hours apart.There was no report of instrument issues at the time of the event.The instrument was in operation.

Manufacturer Narrative

There is no indication that the alleged access total bhcg device was returned for evaluation.The tbhcg reagent lot in question generated patient results of approximately 15-30% greater than the alternate reagent lot and approximately 10% greater than the alternate lot for qc.The product insert states, "the distinct nature of the biological materials used to produce immunoassay reagents, calibrators, and quality controls (qc) contribute to normal variability between lots.This variability, combined with the very low concentrations of analyte immunoassays are designed to measure, typically yields overall imprecision parameters which are higher than chemistry assays.Coefficient of variations (cvs) for chemistry assays are typically 3-6%, while typical cvs for immunoassays are 8-12%." 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
• MDR Report Key: 3671648
• MDR Text Key: 4318642
• Report Number: 2122870-2014-00158
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K023480
• 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: 02/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Catalogue Number: 33500
• Device Lot Number: 325496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2013
• 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