MAUDE Adverse Event Report: BECKMAN COULTER ACCESSTOTAL BHCG; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Catalog Number A85264

Device Problem False Positive Result (1227)

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

Event Date 08/07/2014

Event Type  malfunction  

Event Description

The affiliate stated the customer reported a false positive total beta human chorionic gonadotrophin (tbhcg) result, for one patient, involving the accesstotal bhcg assay used in conjunction with the unicel dxi 800 access immunoassay system.An initial result of 5.40 miu/ml was obtained but was not released out of the laboratory.Subsequent testing of the patient's sample, on the same instrument, generated lower results of 0.28 and 0.32 miu/ml.There was no patient impact associated with this event.The customer indicated all of the system parameters, including quality control (qc), calibration, system check, and carryover, were within specifications.No sample integrity issues were noted.A beckman coulter field service engineer (fse) was dispatched to assess the instrument.

Manufacturer Narrative

There is no indication that the accesstotal bhcg device was returned for evaluation.The field service engineer (fse) verified system operation.No instrument issues were observed.The instrument conformed to the manufacturer's published performance specifications and was returned to normal operation.In conclusion, a definitive cause of the incident could not be determined with the available information.(b)(6).

• Brand Name: ACCESSTOTAL 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: 4065573
• MDR Text Key: 4858061
• Report Number: 2122870-2014-00624
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Type of Report: Initial
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: A85264
• Device Lot Number: 426252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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