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

Model Number TN, HMX AL(198-242/48-62)

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the hmx al instrument generated erroneous mch and mchc results.Review of the results also showed that the instrument generated erroneous high unflagged plt results for patient samples.The fse found that the blood sampling valve (bsv) was defective.The fse replaced the bsv to resolve the issue.The cause of the erroneous results was a defective bsv.The customer did not provide patient age, date of birth, weight or other demographic information for this event.(b)(4).

Event Description

The customer reported erroneously low mean corpuscular hemoglobin (mch) and mean corpuscular hemoglobin concentration (mchc) results were generated on patient samples run on a coulter hmx hematology analyzer.While servicing the instrument, a field service engineer (fse) observed that platelet (plt) results were falsely elevated on a patient run compared to a re-run on the same instrument.There was no report of change or affect to patient treatment associated with this event.

• Brand Name: COULTER HMX 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
• Manufacturer Contact: laurie o'riordan ; 11800 sw 147th avenue, 32-v11; miami, FL 33196-2031 ; 3053802874
• MDR Report Key: 7856231
• MDR Text Key: 119816615
• Report Number: 1061932-2018-01039
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590330569
• UDI-Public: (01)15099590330569(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: K010765
• 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: 09/07/2018

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, HMX AL(198-242/48-62)
• Device Catalogue Number: 6605527
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/09/2018
• Initial Date Manufacturer Received: 08/09/2018
• Initial Date FDA Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2011
• Type of Device Usage: Unknown
• Patient Sequence Number: 1