MAUDE Adverse Event Report: SYSMEX CORPORATION, I SQUARE SYSMEX CS-5100; ATUOMATED COAGULATION ANALYZER

Model Number	CS-5100
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The initial analysis generated masked ptt results [***.*].The sysmex cs-5100 instructions for use (ifu), chapter 3 - principles of operation, section 3.9.2 checking the analysis result list - describes the masks and marks that may be added to analysis data.[***.*] means that analysis result could not be obtained due to errors and other problems.The initial analysis generated the 0008.0128.001 early reaction error: slow reaction.Chapter 7 - troubleshooting, section 7.5.2 analysis data errors - provides the probable cause and corrective actions/countermeasures for error 0009.0128.001 early reaction error: slow reaction: cause: an abnormal reaction was detected at the initial stage of the aptt coagulation reaction.Corrective actions/countermeasures: check the coagulation curve and follow the judgment criteria for your institution.Alternatively, check the volumes of sample and reagent, then repeat the test.This complaint was escalated to the manufacturer, sysmex corporation japan, for investigation.Results are pending.
Event or Problem Description
The operator reported a falsely decreased activated partial thromboplastin time (aptt) to the medical team.The patient received unnecessary heparin treatment based on the erroneous result.No negative impact to the patient was reported due to the unnecessary heparin treatment.
Additional Manufacturer Narrative
This complaint was escalated to the manufacturer, sysmex corporation japan (s-corp), for investigation.The root cause was determined to be a sample specific abnormality, which generated an irregular coagulation curve.The analyzer software performed within specifications, as the results generated with the extended measurement time did not meet flagging criteria.S-corp advised that the concerned facility should switch off the "auto re-analysis" setting with extended measurement time to prevent recurrence.

• Brand Name: SYSMEX CS-5100
• Common Device Name: ATUOMATED COAGULATION 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: william haste ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439459
• MDR Report Key: 15977415
• Report Number: 1000515253-2022-00011
• Device Sequence Number: 17588654
• Product Code: JPA
• UDI-Device Identifier: 04987562425426
• UDI-Public: (01)04987562425426(11)180823
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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: CS-5100
• Device Catalogue Number: BY990757
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Female