MAUDE Adverse Event Report: BECKMAN COULTER COULTER AC·T DIFF 2 ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number	AC*T DIFF 2
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Test Result (2695)
Date of Event	01/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) was on site and confirmed what the customer reported.The cause of the high number of platelets in the patient samples and in the qc results was the aspiration probe being partially obstructed.To resolve the issue the fse replaced the aspiration probe.Bec internal identifier - (b)(4).
Event or Problem Description
The customer reported platelets (plt) running high for all patient samples and qc on their coulter ac·t diff 2 analyzer.Erroneous results with high platelets count were generated for this event.However, the erroneous results were identified by the customer and were not released from lab.There was no impact to patient treatment as a result of the reported event.Neither patient data or raw data were provided by the customer for this event.

• Brand Name: COULTER AC·T DIFF 2 ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 8558389
• Report Number: 1061932-2019-01542
• Device Sequence Number: 2168624
• Product Code: GKZ
• UDI-Device Identifier: 15099590264796
• UDI-Public: (01)15099590264796(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K990352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2019

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: AC*T DIFF 2
• Device Catalogue Number: 6605500
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1