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 05/09/2014

Event Type  malfunction  

Event Description

The affiliate stated the customer reported discrepant total beta human chorionic gonadotrophin (tbhcg) results, for one patient, involving the accesstotal bhcg assay used in conjunction with the unicel dxi 800 access immunoassay system.The customer stated the discrepant results were not released from the laboratory.There was no patient injury or change in patient treatment associated with this event.The patient's sample was collected in a 13x75 mm lithium heparin plasma tube without gel and centrifuged at 2,500 rpm (rotations per minute) for ten minutes, at room temperature.The customer indicated system parameters (system check, calibration, and quality control) passed within assay and instrument specifications prior to the event.A beckman coulter field service engineer (fse) was dispatched to assess the instrument.

Manufacturer Narrative

There is no indication that the total beta human chorionic gonadotrophin (tbhcg) device was returned for evaluation.The field service engineer (fse) removed all pipettors, examined the wash inserts, removed the lock pins and discovered two of the pins were bent.The fse reinstalled the pipettors and aligned all positions, adjusted the voltage and calibrated pressure.The fse then performed a carryover test, system check, and assay calibration.The fse completed all controls, performed 6 repetitions of 15 uil (patient sample), and completed precision and accuracy tests.Service activity performed was verified to meet the specified requirements per established procedures.The instrument conformed to the manufacturer's published performance specifications and was returned to normal operation.Note: the locking pin is used to secure the transducer during tightening of the supply line.If the locking pin were to have been a contributing factor, to the transducers performance, a more systemic pattern would be present.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: 3846557
• MDR Text Key: 4681352
• Report Number: 2122870-2014-00416
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2014
• 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
• Date Manufacturer Received: 05/09/2014
• 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