MAUDE Adverse Event Report: BECKMAN COULTER ACCESS CK-MB; FLUOROMETRIC METHOD, CPK OR ISOENZYMES

Catalog Number 386371

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/16/2014

Event Type  malfunction  

Event Description

The customer reported non-reproducible creatine kinase-mb (ck-mb) results, for two patients, involving the access ck-mb assay used in conjunction with the unicel dxi 600 access immunoassay system.The customer stated the initial questioned results were reported out of the laboratory.The customer was not aware of any impact to patient care.There has been no report of patient injury or change in patient treatment associated with this incident.Subsequent testing of the patients' samples, on an alternate unicel dxi 600 system, generated varied results.The patients' samples were collected in 13x100 mm becton dickinson lithium heparin tubes and centrifuged at 4,000 rpm (rotations per minute) for ten minutes, in ambient temperature.The samples were stored in refrigeration prior to reanalysis.The customer noted a slight cloudiness in the samples but did not observe any sample integrity issues.The customer indicated quality control recovered outside the laboratory's established limits on the original instrument.The customer then completed a 30-replicate precision assessment on the original instrument and a 27-replicate precision assessment on the alternate instrument.The calculated precision was within the expected total imprecision of the ck-mb assay for both instruments.No system issues were reported.The instrument was in operation.

Manufacturer Narrative

There is no indication that the access ck-mb 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: ACCESS CK-MB
• Type of Device: FLUOROMETRIC METHOD, CPK OR ISOENZYMES
• 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: 4146051
• MDR Text Key: 4768360
• Report Number: 2122870-2014-00704
• Device Sequence Number: 1
• Product Code: JHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030012
• 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

• Date FDA Received: 10/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: 386371
• Device Lot Number: 426666
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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