MAUDE Adverse Event Report: BECKMAN COULTER IRELAND INC. DXH500 HEMATOLOGY INSTRUMENT; COUNTER, DIFFERENTIAL CELL

Model Number TN,DXH 500

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

The fields service engineer (fse) could not identify a specific malfunction or faulty part associated to this event.There was no repair or replacement of a component performed.The customer did not call back with a recurrence of the event as of (b)(6)2021.Section a patient information was not provided by the customer.Bec internal identifier case: (b)(6).

Event Description

The customer reported that their dxh 500 hematology instrument generated erroneously high platelet (plt) results on one patient with no flagging or alert on plt clumps the patient sample was initially run on a dxh 800 hematology instrument which generated r flags and a plt result of 14.0 and prompted the operator to review the results.They reran the patient on the dxh 500 generating much higher plt results (125.4) prompting for a manual slide review that coincided with the initial run on the dxh 800 and confirmed plt clumps on the sample.There was no indication of erroneous results being reported outside the laboratory raw data from the instrument was requested but not provided.Patient results were provided and assessed for this event.There was no report of change or effect to patient treatment.There was no adverse event reported as a results of this occurrence.

• Brand Name: DXH500 HEMATOLOGY INSTRUMENT
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER IRELAND INC.; lismeehan; o¿callaghan¿s mills; county clare ; EI
• Manufacturer (Section G): BIT GROUP FRANCE; rue de la valsière,; parc euromédicine ii; montpellier cedex 34090 ; FR 34090
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 11700487
• MDR Text Key: 246495668
• Report Number: 1061932-2021-00060
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590671242
• UDI-Public: (01)15099590671242(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K181475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TN,DXH 500
• Device Catalogue Number: B40601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1