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

Model Number	TN, LH 500 (198-242/48-62)
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) was at the customer site to inspect the instrument.The fse found an air leak in the white blood cell (wbc) dispenser and the red blood cell (rbc) dispenser worn.Patient information for this event was not available.Printouts of the event were requested, but not provided.Bec internal identifier (b)(4).
Event or Problem Description
The customer reported that patient samples recovered erratic results for all parameters on their lh500 hematology instrument.The erroneous results were not reported outside the laboratory.There was no report of death, injury, or change to patient treatment as a result of this event.

• Brand Name: COULTER LH 500 HEMATOLOGY ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 12130101
• Report Number: 1061932-2021-00082
• Device Sequence Number: 19739081
• Product Code: GKZ
• UDI-Device Identifier: 15099590265038
• UDI-Public: (01)15099590265038(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K042724
• 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): 07/07/2021

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 Model Number: TN, LH 500 (198-242/48-62)
• Device Catalogue Number: 178834
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1