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

Catalog Number 386371

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2016

Event Type  malfunction  

Manufacturer Narrative

A beckman coulter (bec) field service engineer (fse) was dispatched to assess the analyzer.The fse requested the customer to perform a special clean and re-ran controls several times.The fse also performed a precision test and assessed system performance.No additional information or issues were reported; therefore, there is insufficient evidence of a hardware or system malfunction.The assignable cause of this event is unknown and cannot be determined with the information provided.All mdrs associated with this event: 2122870-2016-00507, 2122870-2016-00508.

Event Description

The customer reported obtaining a non-reproducible creatine kinase, isoenzyme mb (access ck-mb) results generated from the laboratory's unicel dxi 800 access immunoassay system serial number (b)(4) for a patient sample.On (b)(6) 2016, an elevated access ck-mb result of 46.848 ng/ml was generated.The same sample was repeated and lower results of 2.456 ng/ml and 2.046 ng/ml were obtained.The results were not reported outside of the laboratory.There were no reports of patient injuries or change to patient treatment associated with this event.Mdr 2122870-2016-00507 will address the troponin i (access accutni+3) results obtained on (b)(6) 2016 for this same patient.System parameters including quality controls (qcs) and system checks were recovering within assay and system parameters.Calibration data was not provided for review.The samples were collected in a 13x100 mm lithium heparin tube that was centrifuged at 3000 revolutions per minute (rpm) for 5 minutes at room temperature.A beckman coulter (bec) field service engineer (fse) was dispatched to assess the analyzer's performance.

• Brand Name: ACCESS CK-MB
• Type of Device: FLUOROMETRIC METHOD, CPK OR ISOENZYMES, PRODUCT CODE: JHX
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska 55318
• Manufacturer Contact: angela kilian ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681330
• MDR Report Key: 6060677
• MDR Text Key: 58613380
• Report Number: 2122870-2016-00508
• Device Sequence Number: 1
• Product Code: JHX
• UDI-Device Identifier: 15099590232368
• UDI-Public: (01)15099590232368(17)170430(11)NO-DATA(10)622968
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K030012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 386371
• Device Lot Number: 622968
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/25/2016
• 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