MAUDE Adverse Event Report: BECKMAN COULTER ACCESS TOTAL BHCG (5TH IS) ASSAY; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Catalog Number A85264

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 09/06/2014

Event Type  malfunction  

Event Description

The customer reported obtaining non-reproducible access total beta human chorionic gonadotropin (tbhcg5) results for four (4) patients on four dates involving the unicel dxi 800 access immunoassay system (serial number (b)(4)).This report is related to results generated on (b)(6) 2014 for one (1) patient.There was no change or impact on patient treatment in connection with this event.A review of archive data files indicated all of system parameters, including system checks, quality control (qc) and calibrations were performing within assay and instrument specifications.There were no reports of flags or hardware errors at the time of the event.There were no issues noted or reported with sample collection, sample handling or sample processing for this event.

Manufacturer Narrative

Beckman coulter (bec) field service engineer was not dispatched for this event.There is no indication that access tbhcg5 reagent was returned for evaluation.The customer did not provide the sample to bec for analysis.In conclusion, the cause of this event could not be determined with the supplied information.(b)(6).Associated mdrs with these reports: 2122870-2014-00751 ((b)(6)), 2122870-2014-00752 ((b)(6)), 2122870-2014-00595 ((b)(6)).

• Brand Name: ACCESS TOTAL BHCG (5TH IS) ASSAY
• Type of Device: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• 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: 4212162
• MDR Text Key: 18727534
• Report Number: 2122870-2014-00754
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K130020
• 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: 10/03/2014

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: 02/28/2015
• Device Catalogue Number: A85264
• Device Lot Number: 336130
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2014
• Initial Date FDA Received: 10/29/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2014
• 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
• Patient Age: 34 YR