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

Catalog Number 33500

Device Problem High Test Results (2457)

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

Event Date 09/15/2014

Event Type  malfunction  

Event Description

The customer reported discrepant, elevated total beta human chorionic gonadotrophin (tbhcg) result, for one patient, involving the access total bhcg assay used in conjunction with the unicel dxi 600 access immunoassay system.The customer stated an original result of 1,516 miu/ml was released out of the laboratory and questioned by the physician.The physician sent a new sample to the customer for reanalysis.The retested result, of the new sample - on the same instrument - generated a lower result of 3.6 miu/ml.The customer then retested the original sample, on the same instrument, and obtained a negative result (actual value unknown).The customer stated there was no patient injury or change in patient treatment associated with this event.The patient's sample was collected in 12x75 mm serum separator tube (sst) and centrifuged at 3,500 rpm (rotations per minute) for ten minutes, at room temperature.The sample was allowed to clot for ten minutes prior to centrifugation.The sample was less than six hours following collection and stored in refrigeration.No sample integrity issues were noted.Quality control (qc) is performed once every 24 hours and was within specification at the time of the event.No system issues were noted.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: 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: 4171531
• MDR Text Key: 5092865
• Report Number: 2122870-2014-00720
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2014

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: 06/30/2015
• Device Catalogue Number: 33500
• Device Lot Number: 430080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2014
• Initial Date FDA Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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
• Patient Age: 17 YR