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

Catalog Number 33500

Device Problem High Readings (2459)

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

Event Date 01/22/2014

Event Type  malfunction  

Event Description

The customer reported a non-reproducible initial dil-hcg (diluted beta human chorionic gonadotrophin (bhcg) result, above the normal reference range of the assay, for one patient, involving the access total bhcg reagent used in conjunction with the unicel dxi 600 access immunoassay system.The initial result was released out of the laboratory, and an amended report was generated.The customer stated patient care was not impacted.There was no patient consequence associated with this event.Subsequent testing of the patient's sample, on the same analyzer, produced higher dil-hcg results that did not correlate with the original value.The patient's sample was collected in a serum separator tube with gel and centrifuged at 3,500 rpm (rotations per minute) for ten minutes, at room temperature.The customer noted the sample was full and appeared icteric.The customer stated there had been no issues with quality control (qc); quality control is not performed for dil-hcg.No system issues were noted by the customer and system maintenance was current.All system parameters, including qc and calibration curves were passing within assay and instrument specifications at the time of the event.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 declined service and 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: 3627584
• MDR Text Key: 3986853
• Report Number: 2122870-2014-00120
• 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: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Catalogue Number: 33500
• Device Lot Number: 331063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2013
• 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