MAUDE Adverse Event Report: BECKMAN COULTER IRELAND INC. DXH 500 HEMATOLOGY INSTRUMENT; COUNTER, DIFFERENTIAL CELL

Model Number	TN,DXH 500
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2019, the customer called bec and indicated that their instrument was generating erratic counts for patient results, which are deemed inconsistent when compared to the clinical history of the patient.The customer requested and was guided through the troubleshooting steps to bleach the instrument.The customer bleached the instrument and ran controls all passing, followed by the sample that did not pass initially, and it also passed.The information available reasonably suggests that the instrument required cleaning to remove potential cellular debris that interfered with the parameter counts.Customer maintenance/cleaning was not done as indicated by the ifu.Per dxh 500 instructions for use (ifu) (pn b23922) (march 2017) rev.Ab chapter 12, cleaning procedures, performing the bleach cycle is recommended with the purpose to remove clogs, using high-quality, fragrance-free gel-free bleach (3.6% solution of sodium hypochlorite) with a frequency of every 1, 000 cycles or monthly.Bleach cycle is a special cycle for cleaning the baths and apertures with a bleach solution.
Event or Problem Description
The customer reported that their dxh 500 hematology instrument was generating erroneous high platelet results for a single patient that were deemed inconsistent with the clinical history of the patient.Erroneous results were not reported out of the lab.There was no change or effect to patient treatment as a result of this event.Patient data was not provided by the customer.Per additional information provided by the initial reporter on (b)(6) 2019, the platelet results were considered higher than the expected values for this patient and they were considered erroneous based on the counts provided.The instrument did not trigger any flags or messages for the sample considered erroneous the customer called the bec hotline and stated they had an inconsistency with the results of a patient and requested guidance through performing the bleach cycle procedure for the instrument.The customer had written in their notes that bleaching had to be done every 2 months and had not been done.The customer did not process any more samples until they performed the bleaching of the instrument.

• Brand Name: DXH 500 HEMATOLOGY INSTRUMENT
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER IRELAND INC.; lismeehan; o' callahgan's mills, county c ; EI
• MDR Report Key: 8638859
• Report Number: 1061932-2019-01629
• Device Sequence Number: 11266877
• Product Code: GKZ
• UDI-Device Identifier: 15099590671242
• UDI-Public: (01)15099590671242(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K042724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2019

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,DXH 500
• Device Catalogue Number: B40601
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1