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

Model Number	800
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	05/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2018 the field service engineer (fse) was at the customer site and found that the valves in the pathway to the rbc vacuum chamber were defective causing fluid to remain in the vacuum chamber.The fse replaced valves vl111, vl112 and vl150 from manifold mf103 to resolve the issue.The failure mode is attributed to valves vl111, vl112 and vl150 being defective.Patient information was not provided by the customer.An improvement for plt flagging was developed and released as a part of a software update to the dxh800 that is designated v3.2.1 on (b)(6) 2017; approximately (b)(6)% of the worldwide product installed base has been upgraded as of (b)(6) 2018.Due to an increase in the number of complaints received related to unflagged erroneously high plt patient results released from the lab, bec anticipates that a field action will be warranted.The anticipated field action will include a software patch for the improvement for the plt flagging component of v3.2.1, which will expedite installation of this improvement for the rest of the installed base.(b)(4).
Event or Problem Description
The customer reported that the unicel dxh 800 coulter cellular analysis system generated erroneous high platelet (plt) results on 75 patient samples compared to another dxh800 instrument.The customer provided instrument printouts for six patient samples.Review of the printouts shows that six patient samples gave erroneous high plt results compared to reruns in another dxh800 instrument which were considered correct.Two of the six printouts provided showed instrument flags which alerted the operator to review the results.The other four patients did not show any flags.Raw data or printouts were not provided for the other alleged erroneous results.On (b)(6) 2018, the customer provided more details regarding the reported high plt counts.There was a total of 75 patients that generated false high plt results.The customer reported that their consultant hematologist reported to them that two patients with itp (idiopathic thrombocytopenic purpura) had abnormally high plt results.A patient whose plt value is normally less than 10 gave a plt count of 149 and another patient whose plt value is normally less than 15 gave a plt count of 161.Review of the printouts showed that the erroneous results for the two patients with itp were flagged.This triggered the customer to then review their data and found that there was a total of 75 patient samples that generated false high plt results.The customer also confirmed that the instrument did not generate any flags or messages for plts.However, all the erroneous results were held in the validation queue because of delta check fails, from previous platelet counts and the technician had originally released them without re-evaluation.The customer had not reported the results outside of the laboratory and were able to issue amended reports.The customer reported that there was no change or affect to patient treatment in regards to this event.
Additional Manufacturer Narrative
Follow up 01: an improvement for plt flagging was developed and released as a part of a software update to the dxh800 that is designated v3.2.1 on 22-dec-2017; approximately 11.5% of the worldwide product installed base has been upgraded as of 13-jul-2018.Due to an increase in the number of complaints received related to unflagged erroneously high plt patient results released from the lab, bec has determined that a field action is warranted.Field action (fa-33718) was approved on 30-jul-2018.The field action includes a software patch for the improvement for the plt flagging component of v3.2.1, which will expedite installation of this improvement for rest of the installed base.If follow-up, what type: additional information has been selected.Recall (if recall number is given) or correction/removal number: recall, notification and modification have been selected correction/removal number: number has been updated to reflect the respective information for this event.Additional information: the recall (fa-33718) includes notification to the customer and correction of the issue via software update.Bec internal identifier: (b)(4).

• 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: 7728520
• Report Number: 1061932-2018-01027
• Device Sequence Number: 11125909
• Product Code: GKZ
• UDI-Device Identifier: 15099590672423
• UDI-Public: (01)15099590672423(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair,Recall,Notification,Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

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: 800
• Device Catalogue Number: B24802
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2050012-0730/2018-011
• Patient Sequence Number: 1