MAUDE Adverse Event Report: BECKMAN COULTER COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER; COUNTER, DIFFERENTIAL CELL

Model Number HMX AUTOLOADER 115V (198-242/48-62

Device Problem Output Problem (3005)

Patient Problem Test Result (2695)

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2016, the field service engineer (fse) was at the customer site and observed that qc results were within limits but some parameters were biased high or low.The fse did not specify an instrument malfunction.The fse adjusted the primary calibration factors to resolve the issue.The instrument was verified by the fse.The failure mode is undetermined, an instrument malfunction could not be determined with the information provided.Patient information was not provided for by the customer.Beckman coulter is conducting a retrospective review of its global service records, to ensure that the records had been adequately evaluated for potential complaint information and any warranted follow-up action, including mdr reporting.  this mdr report is a result of that retrospective review.  bec internal identifier - (b)(4).

Event Description

The customer reported that their coulter hmx hematology analyzer with autoloader generated erroneous high platelet (plt) results on patient samples while running in open mode.The customer also stated that the instrument was not matching between modes.There was no report of erroneous results reported out of the lab from the provided information.There was no report of change or effect to patient treatment in connection with the reported event.Patient data was not provided by the customer for this event.

• Brand Name: COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea FL 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: laurie o'riordan ; 11800 sw 147th avenue; miami, FL 33196-2031 ; 3053802874
• MDR Report Key: 7726901
• MDR Text Key: 115375867
• Report Number: 1061932-2018-01017
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590330576
• UDI-Public: (01)15099590330576(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010765
• 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
• Type of Report: Initial
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HMX AUTOLOADER 115V (198-242/48-62
• Device Catalogue Number: 6605526
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1