MAUDE Adverse Event Report: BECKMAN COULTER COULTER ACT DIFF 2 ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number AC*T DIFF 2

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) assisted the customer via telephone.Controls were passing, it seems that they changed qc lots but didn't adjust their ranges for approximately two months.The customer was not a med tech and did not understand the assayed control issue.The fse verified the instrument function with the customer by running fresh tubes of 4c-es controls an reviewed the data with the customer.Recommended to the customer that they should calibrate the instrument whenever they encounter this issue and after any manual calibration.Non instrument malfunction could be identified by the fse.Bec internal identifier - case-(b)(4).

Event Description

The customer reported erroneous high platelet (plt) results on patient samples run on the act diff 2 analyzer after onsite service.There were no erroneous patient results reported outside the laboratory.There was no report of impact to patient treatment.

• Brand Name: COULTER ACT DIFF 2 ANALYZER
• 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 2031
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 10963655
• MDR Text Key: 220233658
• Report Number: 1061932-2020-00175
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590264796
• UDI-Public: (01)15099590264796(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/07/2020

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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1