MAUDE Adverse Event Report: BECKMAN COULTER IRELAND INC DXH500 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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided by the customer.The field service engineer (fse) discovered after the dxh 500 was installed, the reagents on the instrument were not used for a long period of time and the instrument was not calibrated.The fse performed calibration and readjusted the coefficients of dxh500 resolving the reported issue.Bec internal identifier - case-(b)(4).
Event or Problem Description
The customer reported discrepant wbc,rbc,hgb (hemoglobin) and plt (platelet) patient results were recovered on the dxh 500 instrument when compared to the results recovered on their dxh 600 instrument, which were considered correct.Patient data was provided in an excel spreadsheet.Instrument printouts were requested but were not provided by the customer.Instrument flagging of results could not be determined.Erroneous patient results were not reported out of the lab.There was no report of death, injury, or change to patient treatment as a result of this event.

• Brand Name: DXH500 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: 11207745
• Report Number: 1061932-2021-00007
• Device Sequence Number: 11887873
• Product Code: GKZ
• UDI-Device Identifier: 15099590671242
• UDI-Public: (01)15099590671242(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/21/2021

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,DXH 500
• Device Catalogue Number: B40601
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1