BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE

    MDR report key: 8187193 · Received December 20, 2018

    Report

    Report Number
    2954323-2018-09792
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    November 28, 2018
    Report Date
    June 6, 2019
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. 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.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR THIS COMPLAINT. EXTENDED INVESTIGATION WAS PERFORMED AND DETERMINED THAT THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE REPORTED COMPLAINT DOES NOT PERTAIN TO LIBRE READERS. THEREFORE NO FURTHER INVESTIGATION INTO THE READER WILL BE REQUIRED. DHRS (DEVICE HISTORY REVIEW) FOR THE LIBRE SENSOR AND LIBRE SENSOR KIT WERE REVIEWED AND THE DHRS SHOWED THE LIBRE SENSOR AND SENSOR KIT 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. IF THE PRODUCT IS RETURNED, THE CASE WILL BE RE-OPENED AND A PHYSICAL INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A HIGH READINGS ISSUE WITH THE FREESTYLE LIBRE. ON THE EVENING OF (B)(6) 2018 THE CUSTOMER RECEIVED A SENSOR SCAN READING OF 'HI' (GREATER THAN 27.7 MMOL/L), SO SHE TOOK AN UNSPECIFIED AMOUNT OF INSULIN AND THEN "FELT LOW" (UNSPECIFIED SYMPTOMS). THE CUSTOMER WAS TAKEN TO THE HOSPITAL WHERE SHE WAS DIAGNOSED WITH HYPOGLYCEMIA AND GIVEN GLUCOSE "STRIPS" AND OXYGEN FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A HIGH READINGS ISSUE WITH THE FREESTYLE LIBRE. ON THE EVENING OF (B)(6) 2018 THE CUSTOMER RECEIVED A SENSOR SCAN READING OF 'HI' (GREATER THAN 27.7 MMOL/L), SO SHE TOOK AN UNSPECIFIED AMOUNT OF INSULIN AND THEN "FELT LOW" (UNSPECIFIED SYMPTOMS). THE CUSTOMER WAS TAKEN TO THE HOSPITAL WHERE SHE WAS DIAGNOSED WITH HYPOGLYCEMIA AND GIVEN GLUCOSE "STRIPS" AND OXYGEN FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026245 FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC 71702-01

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention