MAUDE Adverse Event Report: BECKMAN COULTER COULTER ACT DIFF 2 HEMATOLOGY INSTRUMENT; HEMATOLOGY ANALYZER

Model Number	AC*T DIFF 2
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	10/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the low control and patient samples recovered with high platelet (plt) results when cycled on the act diff 2 instrument.Erroneous plt results were reported out of the laboratory.However, per conversation with the customer on (b)(6) 2022, there was not death, injury or change to patient treatment due to the event.
Additional Manufacturer Narrative
The field service engineer (fse) was on site and confirmed what the customer reported.The fse performed a decontamination procedure, replaced the vacuum chamber, all check valves, all filters, rbc bath, main board, valves (vl) 16 and 17, wbc bath and performed a latex gain and clot detection procedure as part of troubleshooting.However, the issue was not resolved.To resolve the issue, the fse then replaced the sample probe and associated tubing resolving the event.While onsite, the fse adjusted the calibration factors due to part replacements.Erroneous plt results were reported out of the laboratory.However, per conversation with the customer on (b)(6), 2022, there was not death, injury or change to patient treatment due to the event.Bec internal identifier: (b)(4).

• Brand Name: COULTER ACT DIFF 2 HEMATOLOGY INSTRUMENT
• Common Device Name: HEMATOLOGY ANALYZER
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th ave; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 15655528
• Report Number: 1061932-2022-00066
• Device Sequence Number: 11369732
• Product Code: GKZ
• UDI-Device Identifier: 15099590264796
• UDI-Public: (01)15099590264796(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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