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

Model Number	AC*T DIFF 2
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A beckman coulter field service engineer (fse) was dispatched to the customer¿s site.Upon arrival the fse reviewed the customer¿s control recovery where the wbc showed bias below mean and plt showed bias above mean on all levels of controls; the plt value was also just below the threshold for auto calibration.The fse adjusted the wbc and plt calibration factors resolving the reported issue.Bec internal identifier - case-(b)(4).
Event or Problem Description
The customer reported recovering high erroneous plt results on 2 patient samples run on the ac*t diff 2 instrument.There was no report of erroneous patient results reported outside the laboratory.There was no report of death, injury, or change to patient treatment as a result of this event.The first patient¿s sample (id ending in 4192 actdiff 2) generated a plt of 507, the rerun result was 364.The second patient (id ending in 5165 actdiff 2) generated a plt of 512, the rerun result was 367.

• Brand Name: COULTER ACT DIFF 2 ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• MDR Report Key: 10512496
• Report Number: 1061932-2020-00137
• Device Sequence Number: 3558030
• Product Code: GKZ
• UDI-Device Identifier: 15099590264796
• UDI-Public: (01)15099590264796(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/09/2020

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
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1