MAUDE Adverse Event Report: BECKMAN COULTER ACCESS VITAMIN B 12 REAGENT; RADIOASSAY, VITAMIN B12, PRODUCT CODE: CDD

Catalog Number 33000

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 02/10/2015

Event Type  malfunction  

Event Description

The customer reported non-reproducible vitamin b12 (access vitamin b12) results on the access 2 immunoassay system (serial number (b)(4)) for one patient.The initial access vitamin b12 result was questioned, as the result was below the customer's normal reference range.The sample was repeated two additional times on the same access 2 immunoassay system and recovered with erratic results.One result recovered within the customer's normal reference range the second result recovered below the customer's normal reference range.The initial result was not released from the laboratory.There was no report of patient injury or change in patient treatment associated with this event.As part of trouble shooting, the customer reanalyzed the same patient's serum sample and a plasma sample that was drawn from the patient at the same time.All results recovered below the customer's normal reference range.All system parameters (including quality control (qc), calibration and system check) were within assay/instrument specifications.Beckman coulter (bec) customer technical specialist (cts) advised the customer to perform a precision test.The customer completed two fifteen (15) replicate precision runs, one using qc level one and another using qc level three.Both precision tests met assay specifications.The patient's sample was collected in a serum separator tube.Centrifugation speed, time and temperature were not supplied.No issues with sample integrity were reported by the customer.

Manufacturer Narrative

The customer did not provide patient demographics such as age, date of birth, sex or weight.The vitamin b12 reagent was not returned for evaluation.The cause of this event cannot be determined with the available information.

• Brand Name: ACCESS VITAMIN B 12 REAGENT
• Type of Device: RADIOASSAY, VITAMIN B12, PRODUCT CODE: CDD
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: jeffrey koll ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681361
• MDR Report Key: 4578056
• MDR Text Key: 5450776
• Report Number: 2122870-2015-00147
• 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: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: 33000
• Device Lot Number: 434614
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2014
• 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