BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 3243791 · Received July 23, 2013

    Report

    Report Number
    2954323-2013-00396
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. NOTE: THE DATE OF THE MEDICAL EVENT IS UNKNOWN, THE EVENT DATE ENTERED IS THE DATE WHEN ABBOTT DIABETES CARE BECAME AWARE OF THIS MEDICAL EVENT. NOTE: THE METER'S MANUFACTURE DATE IS UNKNOWN, THE DATE ENTERED IN DEVICE MANUFACTURE DATE IS THE DATE WHEN ABBOTT DIABETES CARE BECAME AWARE OF THIS MEDICAL EVENT.

    Additional Manufacturer Narrative · 1

    THE METER WAS RETURNED AND TESTED WITH RETAINED TEST STRIPS OF A DIFFERENT LOT. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. METER SETTING WAS CHANGED TO BE CURRENT. SETTING DID REMAIN CURRENT OR CORRECT. CONTROL SOLUTION TESTING WAS PERFORMED. DID NOT OBSERVE INCORRECT DATA IN MEMORY. DID NOT OBSERVE "READINGS ARE NOT STORING IN THE METER'S MEMORY." THE COMPLAINT WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    CALLER REPORTED THAT CUSTOMER (HER GRANDCHILD) RECEIVED UNKNOWN ERRATIC READINGS ON HER ADC METER AND SOME READINGS WERE NOT STORED IN THE METER. IT WAS FURTHER REPORTED THESE ISSUES STARTED 2 WEEKS PRIOR TO CALLING CUSTOMER SERVICE AND AT THAT TIME CUSTOMER STARTED EXPERIENCING SYMPTOMS. CALLER STATED THAT CUSTOMER HAD BEEN GIVEN INSULIN BASED ON THE READINGS RECEIVED FROM HER ADC METER, AND THE DOSE OF INSULIN MAY HAVE BEEN INCORRECT. ON AN UNKNOWN DATE CUSTOMER EXPERIENCED SYMPTOMS THAT WERE DESCRIBED AS "CRASHED, VOMITING, DEHYDRATION WHICH CAUSED HER TO GO TO THE E.R. HOSPITAL". CALLER ADDED THAT "SHE COULD NOT SAY EXACTLY THAT THE METER CAUSED HER (CUSTOMER) TO CRASH" AND THAT CUSTOMER "HAD THE FLU AT THAT TIME".MEDICAL SURVEY WAS NOT COMPLETED AND ALTHOUGH CUSTOMER SERVICE MADE SEVERAL ATTEMPTS TO CONTACT CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION, THESE EFFORTS PROVED TO BE UNSUCCESSFUL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342356 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| R