MAUDE Adverse Event Report: BECKMAN COULTER ACCESS VITAMIN B12 ASSAY; RADIOASSAY, VITAMIN B12

Catalog Number 33000

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 06/15/2014

Event Type  malfunction  

Event Description

The customer reported erroneous vitamin b12 results, for multiple patients, involving the access vitamin b12 assay used in conjunction with the unicel dxi 800 access immunoassay system.The customer noted quality control (qc) failed and reanalyzed the last five patients' samples, on the same instrument, and noted discrepant results.The erroneous results were released out of the laboratory, however, there was no report of patient injury or change in patient treatment associated with this event.The customer stated amended reports were issued to the hospital.The customer noted all the erroneous results were generated from a single reagent pack and indicated controls, on a new reagent pack, were acceptable.The patients' samples were frozen serum aliquots.The samples were centrifuged at 5,000 rpm (rotations per minute) for six minutes, at room temperature.No sample integrity issues were reported.A beckman coulter field service engineer (fse) was dispatched to assess the instrument.

Manufacturer Narrative

There is no indication that the access vitamin b12 device was returned for evaluation.The field service engineer (fse) verified the instrument was performing within established specifications.No system issues were noted.The fse identified and noted the erroneous results were generated from a single reagent pack.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.In conclusion, the likely cause of the event is attributed to the vitamin b12 reagent pack.A definitive cause is unknown.

• Brand Name: ACCESS VITAMIN B12 ASSAY
• Type of Device: RADIOASSAY, VITAMIN B12
• 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: 3930726
• MDR Text Key: 4579998
• Report Number: 2122870-2014-00519
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955436
• 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: 06/15/2014

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: 01/31/2015
• Device Catalogue Number: 33000
• Device Lot Number: 336925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2014
• Initial Date FDA Received: 07/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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