BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 14 DAY

    MDR report key: 8866982 · Received August 6, 2019

    Report

    Report Number
    2954323-2019-05998
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    July 7, 2019
    Report Date
    September 12, 2019
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SENSOR (B)(4) HAS BEEN RETURNED AND INVESTIGATED. VISUAL INSPECTION HAS BEEN PERFORMED AND NO ISSUES WERE OBSERVED. EXTRACTED DATA FROM RETURNED SENSOR USING APPROVED SOFTWARE. SENSOR FOUND TO BE IN STATE 5 (INDICATING NORMAL TERMINATION). THE SENSOR PLUG WAS PROPERLY SEATED IN THE MOUNT. REMOVED THE SENSOR PLUG AND INSPECTED THE PLUG ASSEMBLY, NO ISSUES WERE OBSERVED. SENSOR WAS REPROGRAMMED, AND CURRENT WAS APPLIED TO PERFORM LINEARITY TESTING WHILE IN THE TEST FIXTURE. ALL RESULTS WERE WITHIN SPECIFICATION. THE REPORTED COMPLAINT DOES NOT PERTAIN TO THE FREESTYLE LIBRE READER. THEREFORE, NO FURTHER INVESTIGATION INTO THE READER IS REQUIRED. DHRS (DEVICE HISTORY REVIEW) FOR THE FS LIBRE SENSOR AND LIBRE SENSOR KITS WERE REVIEWED AND THE DHRS SHOWED THE LIBRE SENSOR AND LIBRE SENSOR KITS PASSED ALL TESTS PRIOR TO RELEASE. ALL REVIEW ACTIVITIES CONDUCTED ABOVE, INCLUDING BUT NOT LIMITED TO THE FINAL RELEASE TESTING SPECIFICALLY ASSOCIATED WITH THE MANUFACTURE OF THIS PRODUCT, ARE SUFFICIENT INFORMATION IN ORDER TO SHOW IF THE PRODUCT HAS MET SPECIFICATIONS PRIOR TO RELEASE.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED RECEIVING "HI" (GREATER OR EQUAL TO 500MG/DL OR 27MMO/L) WHEN SCANNING THE ADC FREESTYLE LIBRE SENSOR COMPARED TO AN HCP METER. ON 07-JUL-2019, THE CUSTOMER OBTAINED A SCAN OF 27.8MMOL/L (HI) AND CUSTOMER'S WIFE CALLED THE AMBULANCE WHILE THE CUSTOMER EXHIBITED SYMPTOMS OF "SHAKINESS, SWEATING, NOT THINKING STRAIGHT, AND CONFUSION AND SUBSEQUENTLY LOST CONSCIOUSNESS. UPON THE ARRIVAL OF THE EMERGENCY SERVICES, A BLOOD SUGAR OF 2.2MMO/L WAS OBTAINED ON THE HCP METER. THE CUSTOMER WAS ADMITTED TO THE HOSPITAL AND TREATED WITH ORAL GLUCOSE AND AN UNSPECIFIED INJECTION FOR HYPOGLYCEMIA AND DISCHARGED THE SAME DAY. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND DETERMINED THAT THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. SINCE LIBRE READERS DO NOT AFFECT THE RESULTS OF THE SENSOR SCAN AND HAVE THEIR OWN PERCEPTION CODE RELATING TO INACCURATE READINGS, NO FURTHER INVESTIGATION INTO THE READER WILL BE REQUIRED. DHRS (DEVICE HISTORY REVIEW) SHOWED THE LIBRE SENSOR AND LIBRE SENSOR KITS PASSED ALL TESTS PRIOR TO RELEASE. THEREFORE ALL REVIEW ACTIVITIES CONDUCTED ABOVE, INCLUDING BUT NOT LIMITED TO THE FINAL RELEASE TESTING SPECIFICALLY ASSOCIATED WITH THE MANUFACTURE OF THIS PRODUCT, ARE SUFFICIENT INFORMATION IN ORDER TO SHOW IF THE PRODUCT HAS MET SPECIFICATIONS PRIOR TO RELEASE. IF THE PRODUCT IS RETURNED, THE CASE WILL BE RE-OPENED AND A PHYSICAL INVESTIGATION WILL BE PERFORMED. THE DEVICE MFG DATE IS UNKNOWN. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING "HI" (GREATER OR EQUAL TO 500MG/DL OR 27MMOL/L) WHEN SCANNING THE ADC FREESTYLE LIBRE SENSOR COMPARED TO AN HCP METER. ON (B)(6) 2019, THE CUSTOMER OBTAINED A SCAN OF 27.8MMOL/L (HI) AND CUSTOMER'S WIFE CALLED THE AMBULANCE WHILE THE CUSTOMER EXHIBITED SYMPTOMS OF "SHAKINESS, SWEATING, NOT THINKING STRAIGHT, AND CONFUSION AND SUBSEQUENTLY LOST CONSCIOUSNESS. UPON THE ARRIVAL OF THE EMERGENCY SERVICES, A BLOOD SUGAR OF 2.2MMOL/L WAS OBTAINED ON THE HCP METER. THE CUSTOMER WAS ADMITTED TO THE HOSPITAL AND TREATED WITH ORAL GLUCOSE AND AN UNSPECIFIED INJECTION FOR HYPOGLYCEMIA AND DISCHARGED THE SAME DAY. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659171 FREESTYLE LIBRE 14 DAY FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC 71940-01

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention