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

Catalog Number 386371

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

Patient Problem No Information (3190)

Event Date 07/21/2015

Event Type  malfunction  

Manufacturer Narrative

The customer did not provide patient demographics such as age, date of birth, sex or weight.The customer performed a passing system check and fifteen (15) replicate precision run for access accutni+3 and access ck-mb.A beckman coulter (bec) field service engineer (fse) was dispatched to verify instrument performance.The fse made proactive repairs to include replacing the substrate probe, aspirate probes and associated peri-pump tubing and dispense probes.The fse proactively cleaned the wash pump valve and replaced the seals.No hardware or system issues were identified as contributing to the reported event.The access ck-mb reagent was not returned for evaluation.The cause of the reported event cannot be determined with the available information.Mdrs associated with this report: mdr2122870-2015-00496; mdr2122870-2015-00497.(b)(4).

Event Description

The customer stated they noted non-reproducible troponin i (access accutni+3) and creatine kinase-muscle brain isoform (access ck-mb) results for one (1) patient on the laboratory's access 2 immunoassay system portion of the unicel dxc 600i synchron access clinical system ( serial number (b)(4)).The customer repeat tested the sample several times on the same access 2 immunoassay system portion of the unicel dxc 600i synchron access clinical system and obtained lower results, within the normal reference range of the assays.The customer also noted the patient had two subsequent draws that yielded access accutni+3 and access ck-mb results within the normal reference range of the assays.This report addresses the non-reproducible access ck-mb results obtained on (b)(6) 2015.Mdr 2122870-2015-00496 addresses the non-reproducible access accutni+3 results obtained on (b)(6) 2015.The customer stated the elevated access accutni+3 and access ck-mb results were released from the laboratory.The patient was given aspirin.There was no report of additional patient injury or change in patient treatment associated with this event.All system parameters (including quality control (qc), access accutni+3 and access ck-mb calibration, access accutni+3 and access ck-mb precision run and system check) were within assay and instrument specifications.Samples are collected in lithium heparin plasma gel separator tubes and centrifuged at 4500 revolutions per minute (rpm) for three (3) minutes.The customer did not note any issues with sample integrity.

• 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: jeffery koll ; 1000lake hazektine drive; chaska, MN 55318 ; 9523681361
• MDR Report Key: 5005606
• MDR Text Key: 23425974
• Report Number: 2122870-2015-00497
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: 386371
• Device Lot Number: 527148
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/27/2015
• 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