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

Catalog Number	386371
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: FLUOROMETRIC METHOD, CPK OR ISOENZYMES, PRODUCT CODE: JHX
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska 55318
• MDR Report Key: 6060677
• Report Number: 2122870-2016-00508
• Device Sequence Number: 13606096
• Product Code: JHX
• UDI-Device Identifier: 15099590232368
• UDI-Public: (01)15099590232368(17)170430(11)NO-DATA(10)622968
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K030012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 386371
• Device Lot Number: 622968
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2016
• Initial Report FDA Received Date: 10/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1