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

Model Number XN-10

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2021

Event Type  Injury  

Manufacturer Narrative

The user stated the sample was judged "positive" with flags, however the flags were not provided for evaluation.The sysmex xn-1000 instructions for use (ifu), chapter 11 - checking detailed analysis information (data browser), section 11.6 - 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 user-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 the user of possible sample specific abnormalities.The analyzer alerted the operator to possible sample abnormality requiring verification prior to reporting of results.Chapter 9 - analyzing samples, section 9.3 - manual analysis, explains: "if you will not scan a barcode, enter the sample number manually in the input field." it is the responsibility of the operator to ensure the correct sample id is entered into the analyzer.Good laboratory practice requires that the user properly identifies samples.No analyzer deficiency was identified.User error caused this event.

Event Description

A user in (b)(6) ran a patient sample on the analyzer in the sampler mode and received barcode read errors.The user stated the barcode label on the sample was of poor quality.After analysis was complete, the user manually entered an incorrect sample id on the analyzer to sample results belonging to another patient.A low hemoglobin (hgb) result was reported on the wrong patient.An unnecessary transfusion was administered based on the low hgb result.The date and time of the transfusion were not provided.No negative patient impact was incurred due to the transfusion.

• Brand Name: SYSMEX XN-10
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, hyogo 675-0 019; JA 675-0019
• Manufacturer (Section G): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, hyogo 675-0 019; JA 675-0019
• Manufacturer Contact: nancy gould ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439678
• MDR Report Key: 11588608
• MDR Text Key: 243112327
• Report Number: 1000515253-2021-00006
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K112605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• 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: 03/08/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/18/2015
• 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): Other