MAUDE Adverse Event Report: SYSMEX CORPORATION SYSMEX XN-10; AUTOMATED HEMATOLOGY ANALYZER

Model Number XN-10

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/10/2020

Event Type  Injury  

Manufacturer Narrative

The xn-9000 instructions for use (ifu), chapter 11 - checking detailed analysis information (data browser), section 11.5 - interpretive program (ip) messages, details the method in which the analyzer conveys its findings.Results without an error message are categorized as "positive" or "negative" based upon preset criteria, some of which are laboratory-defined.The system bases judgments on comprehensive surveys of numerical data, particle-size distributions, and scattergrams.Flags and messages, communicated through ip messages, indicate the analyzer's findings and notify of possible sample specific abnormalities.Any flag not generated indicates the criteria defined were not met.Review of sample data demonstrates that the setting for ip message "anemia" was not set to the default setting of hemoglobin (hgb) < 10 g/dl.The analyses of samples (b)(6) would have been judged "positive" due to hgb results of < 10 g/dl, had the default setting been applied.No analyzer deficiency was identified.

Event Description

The patient was admitted to the hospital for an unrelated procedure.A bladder biopsy was performed yielding inconclusive results, prompting referral of the sample to a reference laboratory for evaluation.Blood sample analyses for complete blood count (cbc) and cbc with differential (diff) performed over the course of the hospital stay were judged "negative".A cbc with diff analysis collected on the day of discharge was judged "positive", prompting a smear review and discovery of blast cells (blast).A subsequent review of smears from prior samples also yielded blasts.The patient had been discharged before the discovery of blasts.The patient was readmitted and a bone marrow biopsy was performed.The patient diagnosis of acute (non-promyelocytic) myeloid leukemia was delayed by 9 days.No harm to the patient was reported due to the delay.

• Brand Name: SYSMEX XN-10
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION; 314-2 kitano; noguchi-cho; kakogawa, hyogo 675-0 011; JA 675-0011
• Manufacturer (Section G): SYSMEX CORPORATION; 314-2 kitano; noguchi-cho; kakogawa, hyogo 675-0 011; JA 675-0011
• Manufacturer Contact: nancy gould ; 577 aptakisic rd; lincolnshire, il ; 5439678
• MDR Report Key: 10445936
• MDR Text Key: 204192485
• Report Number: 1000515253-2020-00024
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: XN-10
• Device Catalogue Number: AP795756
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 76 YR