MAUDE Adverse Event Report: BECKMAN COULTER IRELAND INC UNICEL DXH 520 HEMATOLOGY INSTRUMENT; COUNTER, DIFFERENTIAL CELL

Model Number	TN,DXH 520 CP HEMATOLOGY INSTRUMENT
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	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The dxh520 operator did not scan the specimen tubes bar code, and did not verify the next specimen id was correct before running the sample.The customer was provided retraining on running samples in primary mode.Per dxh520 v2 ifu, pn b85528aa: creating a worklist.Patient information and specimen ids can be added to a worklist.The information is either downloaded from the host lis system or you can manually enter the information into the worklist.Note: a valid specimen id must be entered to analyze a specimen.If you have set up autoincrementing, the specimen id field will be automatically populated.If no specimen id exists, the system assigns an autosid.Patient information was not provided by the customer.Bec internal identifier: (b)(4).
Event or Problem Description
The beckman coulter applications representative reported the customer was not scanning the barcode on specimen tubes processed on their dxh520 instrument when running samples in primary (closed vial) mode.The customer was not confirming the ¿next specimen id¿ was correct or matching the sample being processed, resulting in patient result misidentification.The reported failure mode occurred when the operator did not scan the sample bar code nor confirmed the next specimen id was correct.The operator acknowledged the ¿ok¿ icon on popup window confirming the ¿next specimen id¿ was correct; then inserts the mixed sample into the tube holder and presses the run icon.Selecting the run icon will close tube holder door and initiate an analytical cycle.On subsequent sample runs, the popup window: ¿verify next specimen id is not displayed¿.However, as specimens are processed, if any entry exist on the worklist, the next specimen id field on the sample analysis - patient results screen automatically displays the first specimen id from the worklist as the next specimen to be processed.The specimen id is used to match the results to an entry on the worklist.There was no death or injury associated with this incident, it was confirmed that no erroneous, or mislabeled results were reported outside the laboratory, and there was no impact or change to patient treatment in this event.

• Brand Name: UNICEL DXH 520 HEMATOLOGY INSTRUMENT
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER IRELAND INC; lismeehan; o¿callaghan¿s mills, co. clare ; EI
• MDR Report Key: 10541592
• Report Number: 1061932-2020-00144
• Device Sequence Number: 14255277
• Product Code: GKZ
• UDI-Device Identifier: 15099590679781
• UDI-Public: (01)15099590679781(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K181475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2020

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 520 CP HEMATOLOGY INSTRUMENT
• Device Catalogue Number: B40602
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1