BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARISOFT

    MDR report key: 21177285 · Received January 17, 2025

    Report

    Report Number
    8021545-2024-05085
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    December 22, 2024
    Report Date
    November 21, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018785
    PMA / PMN Number
    K162812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY. PER REVISION 21 OF PROCEDURE 3709030, A CHILD INVESTIGATION IS NOT REQUIRED TO DOCUMENT THE DHR REVIEW FOR A TYPE 2 REPORTABLE COMPLAINT. HOWEVER, THE CHILD WAS CREATED TO ALLOW THE PARENT RECORD TO ADVANCE TO REVIEW AND SUMMARY. SINCE IT WAS CREATED, THE DHR REVIEW WAS DOCUMENTED WITHIN THE CHILD. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6003427, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003427 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 15 AND PACKAGING IN THE MACHINE MULTIVAC 10 ON 30-SEP-2023, WITH A TOTAL OF (B)(4) UNITS. GLUING TUBE: THE SUB-ASSEMBLY, GLUING TUBE OF THE LOT 3J03443 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 AND MANUFACTURED IN THE MACHINE SC08, ON 23-SEP-2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT A NON-CONFORMANCE (NC) WAS RAISED DUE MISMATCH IN TUBE REQUIRED FOR PRODUCE VARISOFT PRODUCT AND NC WAS RAISED DUE THE HEPA FILTERS OUT OF SPECIFICATION ARE INSIDE THE CLEAN ROOM. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: TWO NONCONFORMANCE (NC) WAS RAISED AND FOUND RELATED TO THE REPORTED MALFUNCTION CODE. HOWEVER, THIS COMPLAINT REQUIRES A FURTHER CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION ASSESSMENT DUE TO FINDINGS IN THE DHR REVIEW ASSOCIATED WITH THE COMPLAINT CODE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2024. THE BLOCKAGE WAS IN THE TUBING. THE BLOOD GLUCOSE LEVEL WAS 479 MG/DL AND THE PATIENT WAS TREATED WITH CORRECTION INJECTION VIA MULTIPLE DAILY INJECTION (MDI). THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465086 VARISOFT UNO COMFORT 60/17 TCAP 10PK INT FPA UNOMEDICAL A/S 1002830 6003427 05705244018785

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male