MAUDE Adverse Event Report: KAKOGAWA FACTORY SYSMEX XS-1000IAL; AUTOMATED HEMATOLOGY ANALYZER

Model Number XS-1000IAL

Device Problem High Readings (2459)

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

Event Date 12/13/2022

Event Type  Injury  

Manufacturer Narrative

The suspect analysis was judged "negative".The sysmex xs-1000i/xs-800i software guide (sg) chapter 6 - appendix, section 6.1 - 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 abnormalities.Any flag not generated indicates the criteria defined were not met.Investigation determined the analyzer performed as designed.The data suggests an inadequately mixed sample processed in the manual mode contributed to the event.No systemic deficiency was identified.When samples are inadequately mixed, rbcs settle toward the bottom of the tube, wbcs and platelets closer to the top, which can lead to the generation of erroneous results.The operator is responsible for proper collection and handling of samples and reporting results with repeat collection and testing when indicated.The sysmex xs-1000i instructions for use (ifu) chapter 3 - design and function, section 3.6 - analysis mode, provides instructions to the user in the manual mode: in manual mode, after mixing a sample manually, place the sample tube in the sample position without removing the cap.Chapter 6 - operation, section 6.11.3 - sample analysis, instructs the user: gently invert sample 10 times.Then place it into the sample position.

Event Description

The user reported an erroneously high hemoglobin (hgb) result was generated.Repeat analysis generated a lower hgb value consistent with the patient's history, and a corrected report was issued.The user alleged a delayed transfusion of two hours.There was no report of harm to the patient due to the transfusion delay.

• Brand Name: SYSMEX XS-1000IAL
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): KAKOGAWA FACTORY; 314-2 kitano; noguchi-cho; kakogawa-city, hyogo 67500 11; JA 6750011
• Manufacturer (Section G): KAKOGAWA FACTORY; 314-2 kitano; noguchi-cho; kakogawa-city, hyogo 675-0 011; JA 675-0011
• Manufacturer Contact: william haste ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439459
• MDR Report Key: 16014216
• MDR Text Key: 305797598
• Report Number: 1000515253-2022-00013
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060656
• 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: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: XS-1000IAL
• Device Catalogue Number: 05342311
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/22/2013
• 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
• Patient Age: 69 YR
• Patient Sex: Male