MAUDE Adverse Event Report: BECKMAN COULTER COULTER AC·T DIFF 2 ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number	AC*T DIFF 2
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	11/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2016, the field service engineer (fse) was at the customer site and observed an abnormal plt histogram and found that plt counts were elevated on the ac*t diff 2 instrument.The fse found that the probe was restricted and replaced the probe to resolve the issue.The repairs were verified by the fse.The failure mode is attributed to the probe which was replaced by the fse.Patient information was not provided by the customer.Beckman coulter is conducting a retrospective review of its global service records, to ensure that the records had been adequately evaluated for potential complaint information and any warranted follow-up action, including mdr reporting.  this mdr report is a result of that retrospective review.  (b)(4).
Event or Problem Description
The customer reported that their coulter ac·t diff 2 analyzer generated erroneous high platelet (plt) results on three patient samples.The customer also stated that controls were failing for plts after the event was identified.There was no report of erroneous results reported out of the lab from the provided information.There was no report of change or effect to patient treatment in connection with the reported event.Patient data was not provided by the customer for this event.

• Brand Name: COULTER AC·T DIFF 2 ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• MDR Report Key: 7726894
• Report Number: 1061932-2018-01018
• Device Sequence Number: 19058427
• Product Code: GKZ
• UDI-Device Identifier: 15099590264796
• UDI-Public: (01)15099590264796(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2018

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2016
• Initial Report FDA Received Date: 07/27/2018
• Patient Sequence Number: 1