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

Model Number TN, ACT5DIFF AL 100-240V

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2019

Event Type  malfunction  

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).

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 Description

Platelets erroneous results.

• Brand Name: COULTER ACT
• Type of Device: 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
• Manufacturer Contact: laurie o'riordan ; 11800 sw 147th avenue; miami, FL 33196-2031
• MDR Report Key: 9159319
• MDR Text Key: 185016986
• Report Number: 1061932-2019-01846
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590576479
• UDI-Public: (01)15099590576479(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TN, ACT5DIFF AL 100-240V
• Device Catalogue Number: 175356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/05/2019
• Date Manufacturer Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 77 YR