MAUDE Adverse Event Report: BECKMAN COULTER COULTER ACT 5DIFF CP HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number	ACT 5DIFF CP 100-240V
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	11/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the traverse on the act 5 diff cp hematology analyzer was not reaching home.High unflagged platelet (plt) values and plt vote outs were also recovered for patient samples.Erroneous results generated from the analyzer, however, erroneous results reported out of the lab.There was no report of death, injury, or change to patient treatment as a result of this event.Instrument data of three (3) patient samples were provided for review.On (b)(6) 2021, patient 1 sample was run in cbc mode on the act 5 diff cp recovering high plt results of 724 x 103 cells/l with no plt specific instrument suspect messages.The patient¿s sample was rerun (x3) on the same day recovering lower plt results of 192, 123 and 105 x 103 cells/l respectively.The customer performed shutdown, startup and qc which recovered within the expected range.The patient¿s sample was reran recovering a plt result of 105 x 103 cells/l which was considered correct.On (b)(6) 2021, patient 2 and patient 3 samples were run on the act 5 diff cp instrument recovering results with plt vote outs, diff ¿r¿ flags, plt interpretation not possible, nrbc and plt aggregates instrument interpretive messages.
Additional Manufacturer Narrative
The field service engineer (fse) inspected the instrument but could not determine the cause of the high plt issue concluding the cause may be related to a transient event.The fse determined the cause of the diff ¿r¿ flags was due to reagent that was close to expiration.The customer performed shutdown, startup and qc which recovered within the expected range.Bec internal identifier (b)(4).

• Brand Name: COULTER ACT 5DIFF CP HEMATOLOGY ANALYZER
• 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: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 13006904
• Report Number: 1061932-2021-00176
• Device Sequence Number: 17503207
• Product Code: GKZ
• UDI-Device Identifier: 15099590579005
• UDI-Public: (01)15099590579005(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K042173
• 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): 12/14/2021

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: ACT 5DIFF CP 100-240V
• Device Catalogue Number: 6605641
• 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: 11/23/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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