MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 780 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number	TN, LH780 ANALYTICAL STATION
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	07/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) examined the rbc and wbc dispensers and was not able to find a malfunction.The fse identified the issue to be an air-mixing issue in the diluent line.The fse primed the diluent resolving the event.The instrument operational.The fse verified instrument operation with startup and quality control.All recovered within specification without error.Patient demographics were not provided for the data provided by the customer.Bec internal identifier - case- (b)(4).
Event or Problem Description
The customer reported the platelet (plt) parameter recovered high for approximately six patient samples without suspect messaging when cycled on their coulter lh 780 hematology analyzer.The customer also reported air bubbles in the wbc dispenser during the event.Per documentation, no erroneous results were reported out of the laboratory.Questioned samples with high platelets were rerun and reported from a different analyzer.Controls recovered within specification before and after the event.There was no death or injury associated with this incident, no erroneous results were reported outside the laboratory and there was no impact or change to patient treatment.Only one printout for one patient result was provided by the customer, the other five could not be confirmed.

• Brand Name: COULTER LH 780 HEMATOLOGY ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 10418363
• Report Number: 1061932-2020-00130
• Device Sequence Number: 3105020
• Product Code: GKZ
• UDI-Device Identifier: 15099590282431
• UDI-Public: (01)15099590282431(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061616
• 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): 08/17/2020

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, LH780 ANALYTICAL STATION
• Device Catalogue Number: 723585
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2020
• Initial Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1