MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN DXH 800 HEMATOLOGY SYSTEM
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	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported incorrect result / false h & h critical result flagged /wbc /rbc /hgb/hct/ mch/mchc / platelets higher // on one sample.There were indications of erroneous results being reported outside the laboratory, leading to one patient receiving one unit of blood.The erroneous results were not confirmed by that laboratory and it is unknown if that transfusion was required.No patient history was available.There was neither death or serious injury associated with the event.Based on the information provided, there is no sufficient evidence that reasonably suggests a malfunction.Based on the servicemax service request ca-06603370 dated march-09-2024, the customer technical specialist (cts) assisted the customer's reported issue.The cts confirmed this issue was isolated to one patient sample.The reported issue could not be reproduced by the cts, and no instrument malfunction was identified.The customer agreed with the solution and did not call back to report any issues.Service records for the instrument have been reviewed and there is no report of a recurrence of this event by the customer.System was verified to meet published performance specifications.The system is considered operational.The reported issue could not be reproduced by the cts, and no instrument malfunction was identified.The laboratory released the results without further testing.
Additional Manufacturer Narrative
Section a - patient information was not provided.The field service engineer (fse) indicated that controls were ran before and after this event, and they were passing, meeting the published performance specifications.The reported issue could not be reproduced by the cts, and no instrument malfunction was identified.The customer agreed with the solution and did not call back to report any issues.Service records for the instrument have been reviewed and there is no report of a recurrence of this event by the customer.System was verified to meet published performance specifications.The system is considered operational.Bec internal identifier (b)(4).

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 9523681224
• MDR Report Key: 19050981
• Report Number: 1061932-2024-00003
• Device Sequence Number: 15280904
• Product Code: GKZ
• UDI-Device Identifier: 15099590381646
• UDI-Public: (01)15099590381646(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2024

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 800 HEMATOLOGY SYSTEM
• Device Catalogue Number: 629029
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown