MAUDE Adverse Event Report: BECKMAN COULTER ACCESS VITAMIN B12; 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 12/02/2014

Event Type  malfunction  

Event Description

The customer reported obtaining an erroneous vitamin b12 result for one patient sample on the laboratory's unicel dxi 600 access immunoassay system (serial number (b)(4)).The initial result obtained was >1500 pg/ml, which was reported out of the laboratory.The patient was expected to be within the normal reference range for vitamin b12.The sample was diluted 1:5 and re-analyzed on the same instrument, which yielded 453 pg/ml, which was in the normal reference range.There is no report of patient injury or change to patient treatment in connection with this event.The sample was centrifuged at 3000 rpm for 8 minutes.System check passed on (b)(4) 2014.The customer sent the patient sample to beckman coulter for sample interference testing.Reference range for access vitamin b12: 180 - 914 pg/ml.

Manufacturer Narrative

The customer did not provide the patient's weight.There is no indication that the access vitamin b12 reagent used by the customer was returned for evaluation.Beckman coulter analysis of the patient sample indicated evidence of alkaline phosphatase (alp) interference, as vitamin b12 was reduced by 74% with the addition of alp blocker.The instructions for use for access vitamin b12 does not include a limitation for alp interference.

• Brand Name: ACCESS VITAMIN B12
• 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: 4376635
• MDR Text Key: 5115888
• Report Number: 2122870-2015-00001
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140496
• 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: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: 33000
• Device Lot Number: 430162
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2014
• 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: 73 YR