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 07/24/2014

Event Type  malfunction  

Event Description

The customer reported a unicel dxi 800 access immunoassay system (serial number (b)(4)) generated non-reproducible total beta human chorionic gonadotropin (tbhcg5) results for four patient samples on four dates.This mdr reports the results generated on (b)(6)2014 for one patient.There were no reports of impact to patient treatment in connection with this event.The customer did not report any instrument-generated flags or hardware errors at the time of the event.There were no issues noted with sample collection, sampling handling, or sampling processing.A review of the instrument's archived data files indicates that system parameters including system checks, quality control results, and calibrations for tbhcg5 were within assay and instrument specifications for the date of this event.

Manufacturer Narrative

Beckman coulter (bec) field service was not dispatched to evaluate the instrument.There was no indication the access tbhcg reagent was returned to bec for investigation.The patient sample was sent to the bec complaint handling unit (chu) for testing.The sample was centrifuged and tested neat, in duplicate, by an access 2 immunoassay system (serial number (b)(4)), which generated reproducible tbhcg5 results; the customer's reported issue could not be duplicated.In conclusion, the cause of the non-reproducible tbhcg5 results could not be determined with the supplied information.(b)(6).All associated mdrs: 2122870-2014-00595, 2122870-2014-00751, 2122870-2014-00754.

• 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: 4220053
• MDR Text Key: 4969202
• Report Number: 2122870-2014-00752
• 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: 11/30/2014
• Device Catalogue Number: A85264
• Device Lot Number: 333264
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2014
• Initial Date FDA Received: 11/03/2014
• 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
• Patient Age: 50 YR