BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 6510246 · Received April 21, 2017

    Report

    Report Number
    2954323-2017-03185
    Event Type
    Injury
    Date Received
    April 21, 2017
    Date of Event
    March 19, 2017
    Report Date
    April 3, 2018
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S PRODUCTS HAVE BEEN REQUESTED FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE PRODUCT PROBLEM WAS FILED UNDER ADC CASE # (B)(4), REF NO. 2954323-2017-02321-00. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AN EXTENDED INVESTIGATION HAS BEEN CONDUCTED, WHICH INVOLVED A MANUFACTURING REVIEW (INCLUDING 5 YEARS OF DEVICE HISTORY RECORDS (DHRS)), PREVIOUS COMPLAINT AND CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATIONS CONDUCTED FOR BLANK SCREEN ISSUES, PROCESS FAILURE MODE EFFECTS ANALYSES (PFMEAS), DESIGN CONTROLS, AND DESIGN FAILURE MODE EFFECTS ANALYSES (DFMEAS), RISK MANAGEMENT REPORTS, RISK EVALUATIONS, AND LABEL COPY. THE INVESTIGATION DID NOT IDENTIFY ANY INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. IF THE PRODUCT IS RETURNED, AN INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    THIS SERVES AS A CORRECTION REPORT. (CUSTOMER WEIGHT), (ADVERSE EVENT/PRODUCT PROBLEM), (DESCRIBE EVENT OR PROBLEM) AND (TYPE OF REPORTABLE EVENT) WERE INCORRECTLY DOCUMENTED IN THE MDR FOLLOW UP #1 REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2017 A CUSTOMER REPORTED THAT HIS ADC BLOOD GLUCOSE METER WOULD NOT TURN ON WITH THE BUTTON OR TEST STRIP. ON (B)(6) 2017, THE CUSTOMER CONTACTED ADC TO TRACK THE DELIVERY OF THE REPLACEMENT METER, WHICH HAD NOT ARRIVED. AS A RESULT OF NOT HAVING A METER TO TEST WITH, THE CUSTOMER REPORTED THAT ON (B)(6) 2017 AT 1:00 PM HE FELT DIZZY, AND CALLED 911. WHEN 911 DID NOT ARRIVE, THE CUSTOMER¿S WIFE TRANSPORTED HIM TO THE EMERGENCY ROOM AT 2:00 PM. IN THE ER, MULTIPLE LAB TESTS WERE PERFORMED AND THE CUSTOMER WAS FOUND TO HAVE A HIGH POTASSIUM LEVEL. A NURSE TESTED HIS GLUCOSE LEVEL WITH A RESULT OF 120 MG/DL. THE CUSTOMER REPORTED RECEIVING FOOD ("CRANBERRY JUICE DIET") AFTER THE READING OF 120 MG/DL WAS OBTAINED. ADDITIONALLY, THE CUSTOMER WAS REPORTEDLY INJECTED WITH INSULIN AND PLACED ON AN ¿IV¿ (CUSTOMER DID NOT KNOW THE DOSE OF THE INSULIN OR CONTENTS OF THE IV). CUSTOMER¿S BLOOD GLUCOSE WAS TESTED AGAIN AFTER DINNER WITH A RESULT OF 144 MG/DL. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2017 A CUSTOMER REPORTED THAT HIS ADC BLOOD GLUCOSE METER WOULD NOT TURN ON WITH THE BUTTON OR TEST STRIP. ON MAR 22, 2017, THE CUSTOMER CONTACTED ADC TO TRACK THE DELIVERY OF THE REPLACEMENT METER, WHICH HAD NOT ARRIVED. AS A RESULT OF NOT HAVING A METER TO TEST WITH, THE CUSTOMER REPORTED THAT ON (B)(6) 2017 AT 1:00 PM HE FELT DIZZY, AND CALLED 911. WHEN 911 DID NOT ARRIVE, THE CUSTOMER¿S WIFE TRANSPORTED HIM TO THE EMERGENCY ROOM AT 2:00 PM. IN THE ER, MULTIPLE LAB TESTS WERE PERFORMED AND THE CUSTOMER WAS FOUND TO HAVE A HIGH POTASSIUM LEVEL. A NURSE TESTED HIS GLUCOSE LEVEL WITH A RESULT OF 120 MG/DL. THE CUSTOMER REPORTED RECEIVING FOOD ("CRANBERRY JUICE DIET") AFTER THE READING OF 120 MG/DL WAS OBTAINED. ADDITIONALLY, THE CUSTOMER WAS REPORTEDLY INJECTED WITH INSULIN AND PLACED ON AN ¿IV¿ (CUSTOMER DID NOT KNOW THE DOSE OF THE INSULIN OR CONTENTS OF THE IV). CUSTOMER¿S BLOOD GLUCOSE WAS TESTED AGAIN AFTER DINNER WITH A RESULT OF 144 MG/DL. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292180 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC. 71501-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention