MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN,DXH 800 HEMATOLOGY SYSTEM
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	06/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2018, the field service engineer (fse) confirmed the customer did not review the sample results prior to releasing per established lab protocol.Although there was no malfunction identified, bec is reporting the transfusion event in an abundance of caution.Per unicel dxh series with system manager software instructions for use (ifu): flags, codes, and messages are evaluated when the sample is analyzed.Beckman coulter does not claim to identify every abnormality in all samples.Beckman coulter suggests using all available options to optimize the sensitivity of instrument results.Beckman coulter recommends avoiding the use of one type of message or output to summarize results or patient conditions.(b)(4).
Event or Problem Description
The customer reported recovering discrepant cbc results on a single patient sample run on their unicel dxh 800 coulter cellular analysis system (dxh8001).The customer stated the patient¿s sample was run on two of the lab¿s dxh 800 instruments; the results were considered erroneous when the results from the dxh 8002 instrument did not match the results generated by the dxh 8001 instrument.Instrument printouts provided for review confirmed on (b)(6) 2018, discrepant cbc results were recovered on the dxh8002 instrument, in particular lower wbc, rbc, hgb, hct, and mchc with no instrument suspect messages when compared to the results recovered on the dxh 8001 instrument.Per telephone conversation with the customer on (b)(6) 2018, the customer confirmed the erroneous results were reported to the physician and the patient transfused based on the initial hgb-5.3 and hct-18.7 results.A manual slide review of the patient¿s sample was not performed.All controls recovered within specification.

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 7918811
• Report Number: 1061932-2018-01043
• Device Sequence Number: 1914232
• Product Code: GKZ
• UDI-Device Identifier: 15099590381646
• UDI-Public: (01)15099590381646(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K140911
• 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): 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TN,DXH 800 HEMATOLOGY SYSTEM
• Device Catalogue Number: 629029
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/06/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR