MAUDE Adverse Event Report: BECKMAN COULTER COULTER ACT; COUNTER, DIFFERENTIAL CELL

Model Number	TN, ACT5DIFF AL 100-240V
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per service request (b)(4) dated sep 5th, 2019, the field service engineer (fse) tracked the results in both analyzers, finding all the results obtained for the patient samples in question.The fse provided the lis logs showing that the operator manually edited the platelets values from zero (0) to 63.The fse instructed the customer, that in the future, the platelet results that are lower than the lower limit of linearity: 10.0 x 10power3 /ul, should be reported as ¿lower than linearity¿.The fse showed to the customer were to find the linearity values in the ifu spanish.A patient sample, without demographics, was run in sep 3rd, 2019 and recovered a flagged platelet count of 62 , flagged al (abnormally low).These results are not comparable with the historical results of the affected patient.The customer confirmed thrombocytopenia with a manual slide and with a blood sample draw into a vial with citrate as anticoagulant.On (b)(6) 2019, the fse reported that the patient diagnosis was thrombocytopenic purpura.On (b)(6) 2019 the fse contacted the customer confirmed that there was no report made to the lab about impact to patient treatment.The available information reasonably suggests that results were manually edited by the customer on the lis.The zero (0) results correlated with the patient history, however, the operator overwrote the zero (0) platelets results to 63 platelets and those results were reported outside the lab.Bec internal identifier - (b)(4).
Additional Manufacturer Narrative
The field service engineer (fse) evaluated the instrument at the customer's site and obtained the patient data.The fse confirmed that the laboratory information system logs show the customer manually changed the result from zero to 63.There was no issue found with the instrument.The cause of the erroneously elevated plt result of 63 is unknown at this time.
Event or Problem Description
Platelets erroneous results.

• Brand Name: COULTER ACT
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• MDR Report Key: 9159319
• Report Number: 1061932-2019-01846
• Device Sequence Number: 11330030
• Product Code: GKZ
• UDI-Device Identifier: 15099590576479
• UDI-Public: (01)15099590576479(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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: TN, ACT5DIFF AL 100-240V
• Device Catalogue Number: 175356
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/05/2019
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 12/03/2019
• Patient Sequence Number: 1
• Patient Age: 77 YR