MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 500 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number TN, LH 500 (108-132/48-62)

Device Problem Output Problem (3005)

Patient Problem Test Result (2695)

Event Date 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

On 30 jan 2017, the field service engineer (fse) was at the customer site and replaced the rbc bath and aperture on the coulter lh 500 hematology analyzer to resolve the issue.The repairs were verified by the fse.The failure mode is the rbc bath and aperture that were replaced by the fse.Patient information was not provided by the customer for this event.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)(6).

Event Description

The customer reported that the coulter lh 500 hematology analyzer generated erroneous high platelet (plt) results on patient samples.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.Instrument printouts of patient results or controls were not provided for this event.

• Brand Name: COULTER LH 500 HEMATOLOGY ANALYZER
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 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: 7726900
• MDR Text Key: 115796310
• Report Number: 1061932-2018-01021
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590265045
• UDI-Public: (01)15099590265045(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042724
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TN, LH 500 (108-132/48-62)
• Device Catalogue Number: 178833
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1