MAUDE Adverse Event Report: BECKMAN COULTER ACCESS TOTAL BHCG (5TH IS); 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 05/09/2015

Event Type  malfunction  

Event Description

The customer reported a non-reproducible human chorionic gonadotropin (access total bhcg (5th is)) result on the unicel dxi 600 immunoassay system (serial number (b)(4)) for one patient.The initial access total bhcg (5th is) result was repeated as the result was within the customer's protocol for repeat analysis.The sample was repeated three (3) times on the same unicel dxi 600 immunoassay system and recovered with higher results.The same patient's sample was also analyzed on the laboratory's alternative access 2 immunoassay system (serial number (b)(4)) and a result within the customer's expectations was obtained.The results were not released from the laboratory.There was no report of patient injury or change in patient treatment associated with this event.System parameters including quality control (qc) and system check were within assay/instrument specifications.A ten (10) repetition precision study was performed using level 2 qc.The precision study met assay and system specifications.The patient's sample was a fresh sample collected in a 13 x 100 mm becton & dickinson (bd) gel tube and centrifuged at a speed of 4000 revolutions per minute (rpm) for ten (10) minutes.No issues with sample integrity were reported by the customer.

Manufacturer Narrative

The access total bhcg (5th is) reagent was not returned for evaluation.All assay and system verifications met specifications.The cause of this event cannot be determined with the available information.

• Brand Name: ACCESS TOTAL BHCG (5TH IS)
• Type of Device: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska 55318
• Manufacturer Contact: jeffrey koll ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681361
• MDR Report Key: 4815878
• MDR Text Key: 5895739
• Report Number: 2122870-2015-00327
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 05/09/2015

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: 12/31/2015
• Device Catalogue Number: A85264
• Device Lot Number: 434882
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2015
• Initial Date FDA Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2015
• 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