MAUDE Adverse Event Report: BECKMAN COULTER ACCESS® TOTAL BHCG; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Catalog Number 33500

Device Problems False Reading From Device Non-Compliance (1228); High Test Results (2457)

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

Event Date 03/13/2014

Event Type  malfunction  

Event Description

The affiliate stated the customer reported falsely elevated beta human chorionic gonadotrophin (bhcg) result, for one patient, involving the access® total bhcg reagent used in conjunction with the access® 2 immunoassay system.The customer stated the falsely elevated result was released out of the laboratory.There was no report of patient injury or change in patient treatment associated with this event.The physician requested the sample be reanalyzed as an alternate methodology produced a negative bhcg result.The patient's sample was reanalyzed, on the same instrument, and generated lower results, within the normal reference range of the assay.The patient's sample was collected in 6 ml serum separation tube (sst) and centrifuged at 3,000 rpm (rotations per minute) for ten minutes.The sample was stored at ambient temperature.No sample integrity issues were noted.The customer stated quality control (qc) was within the laboratory's established limits prior to and after the event.No system issues were reported.The instrument was in normal operation.

Manufacturer Narrative

There is no indication that the access® total bhcg device was returned for evaluation.Service was not dispatched as the customer did not question system performance.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: 3778862
• MDR Text Key: 4441461
• Report Number: 2122870-2014-00317
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Catalogue Number: 33500
• Device Lot Number: 370193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2013
• 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