MAUDE Adverse Event Report: BECKMAN COULTER IRELAND INC UNICEL DXH 500 HEMATOLOGY INSTRUMENT; COUNTER, DIFFERENTIAL CELL

Model Number	TN,DXH 500
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field applications analyst in (b)(6) reported that ¿the sample barcode was scanned for a patient and the demographics appeared on the printout and on the result screen were of another patient, and it also got transferred though lis and reported to the patient." to correct the reported issue, the applications analyst recommended to the customer that they to switch auto work list option off from the lis.The analyst also suggested to check the barcode number on the screen after scanning.¿ the available information reasonably suggests this issue was a use error.The operator was not doing verifications as instructed by our labeling and the auto work list function was not being used properly.Patient data was not provided.The unicel dxh 500 hematology instrument is not currently available in the united states, however, unicel dxh 520 hematology instrument is an ivd instrument and is a similar device to the dxh520.This event is being filed under the 510k for the dxh520.Bec internal identifier - case-(b)(4).
Event or Problem Description
Sample results of one patient were reported out of the lab as another patient's results, the event occurred on a dxh500 at a customer site in (b)(6).The operator scanned a sample and the demographics on the printout were of another patient found on the work list that was generated automatically by the lis.There was no death or injury reported as a result of this event.Impact to patient treatment was requested, but not provided.

• Brand Name: UNICEL DXH 500 HEMATOLOGY INSTRUMENT
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER IRELAND INC; lismeehan; o' callahgan's mills, county c ; EI
• MDR Report Key: 9645078
• Report Number: 1061932-2020-00009
• Device Sequence Number: 2041085
• Product Code: GKZ
• UDI-Device Identifier: 15099590671242
• UDI-Public: (01)15099590671242(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K181475
• 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): 01/29/2020

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,DXH 500
• Device Catalogue Number: B40601
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1