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

Catalog Number 386371

Device Problem High Test Results (2457)

Patient Problem Misdiagnosis (2159)

Event Date 05/29/2015

Event Type  Injury  

Event Description

The customer reported obtaining a non-reproducible creatine kinase m sub-unit/b sub-unit (access ck-mb) result involving the unicel dxi 800 access immunoassay system serial number (b)(4) for one (1) patient.The patient's sample was reanalyzed on the same unicel dxi 800 access immunoassay system and a lower result, within the laboratory's normal reference range, was obtained.The elevated access ck-mb result was released from the laboratory.There was a report of a change in patient treatment as the customer stated that the patient was admitted to the hospital in association with the elevated access ck-mb result.Quality control (qc), calibration, precision, and system check were performing within assay and instrument specifications at the time of the event.The sample was serum, collected in a serum separator gel tube.The sample was centrifuged on the automation line for six (6) minutes at 30,000 rpm (revolutions per minute).The customer indicated the sample contained fibrin.

Manufacturer Narrative

There is no indication the access ck-mb reagent was returned for evaluation.A beckman coulter (bec) field service engineer (fse) was not dispatched.System parameters of quality control (qc), calibration, precision, and system check were performing within assay and instrument specifications.In conclusion, the cause of the event was pre-analytical sample handling as the sample contained fibrin.(b)(4).

• Brand Name: ACCESS CK-MB REAGENT
• Type of Device: FLUOROMETRIC METHOD, CPK OR ISOENZYMES
• 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: 4856156
• MDR Text Key: 22026292
• Report Number: 2122870-2015-00358
• 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: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Catalogue Number: 386371
• Device Lot Number: 437908
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2015
• Initial Date FDA Received: 06/19/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2015
• 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 Outcome(s): Hospitalization