BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1013129 · Received March 11, 2008

    Report

    Report Number
    2939301-2008-00289
    Event Type
    Injury
    Date Received
    March 11, 2008
    Report Date
    March 4, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    A DIABETIC NURSE CONTACTED LIFESCAN (LFS) IN 2008 ALLEGING INACCURATE READINGS ON A PT'S ONE TOUCH ULTRA 2 METER. THE CUSTOMER CARE ADVOCATE (CCA) CONTACTED THE PT'S MOTHER TO OBTAIN INFO. A MEDICAL AFFAIRS SPECIALIST (MAS) STENT FOLLOW UP QUESTIONS; HOWEVER, THE CUSTOMER SERVICE ADVOCATE (CCA) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PT TO ASK ANY ADD'L QUESTIONS. ON THE MONTH BEFORE AT 7:00 PM, PRIOR TO GOING TO BED, THE MOTHER TESTED HER SON'S BLOOD GLUCOSE AND OBTAINED A 4.8 MMOL/L (86 MG/DL). HE EXHIBITED SYMPTOMS OF HIGH BLOOD GLUCOSE (THIRSTY AND WANTING TO URINATE) PRIOR TO TESTING. SHE GAVE HER SON SOME APPLE JUICE AND TESTED HIS BLOOD GLUCOSE 30 MINUTES LATER AND OBTAINED A 4.2 MMOL/L (75 MG/DL). SHE THEN TREATED HIM WITH A 100 MILLILITER OF STRAWBERRY MILKSHAKE. SHE TESTED 30 MINUTES LATER AND HIS BLOOD GLUCOSE WAS 3.8 MMOL/L (68 MG/DL). SHE KNEW THAT THERE WAS SOMETHING WRONG WITH THE DEVICE, SINCE HIS SYMPTOMS WERE NOT CONSISTENT WITH HIS BLOOD GLUCOSE READINGS. SHE THEN TESTED HER SON USING ANOTHER ULTRA 2 METER WITH A DIFFERENT VIAL OF TEST STRIPS AND OBTAINED A 28 MMOL/L (504 MG/DL). SHE THEN ADMINISTERED 1.8 UNITS OF INSULIN TO BRING THE LEVEL DOWN. THE PT DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT THE PHYSICIAN FOR ADVICE. SHE STARTED TO USE THE NEW VIAL OF TEST STRIPS AND THE PT'S READINGS WERE CONSISTENT WITH HIS SYMPTOMS. THE CONDITION OF THE SUBJECT TEST STRIPS WAS IN GOOD CONDITION AND NOT EXPIRED. THE MOTHER WAS UNABLE/UNWILLING TO VERIFY WHETHER SHE HAD THE CORRECT VIAL OF CONTROL SOLUTION. CCA SENT THE PT REPLACEMENT STRIPS AND CONTROL SOLUTION. NO FURTHER CLINICAL INFO WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT THE PT'S READINGS WERE PRIOR TO THE INCIDENT, WHAT HIS BLOOD GLUCOSE READING WAS AFTER BEING TREATED WITH INSULIN, HOW LONG HIS SYMPTOMS LASTED AND A NORMAL BLOOD GLUCOSE READING FOR THE PT. THE COMPLAINT IS BEING REPORTED, SINCE THE MOTHER ALLEGES SHE INITIALLY TREATED THE PT BASED ON INACCURATELY LOW READINGS ON THE LFS PRODUCT THAT DID NOT CORRELATE WITH THE PT'S SYMPTOMS THAT SUGGESTED HYPERGLYCEMIA AND WITH A LATER READING ON ANOTHER LFS PRODUCT THAT GAVE A HYPERGLYCEMIC READING. NO INFO WAS PROVIDED REGARDING THE PT'S METER READINGS OR DIABETES TREATMENT ACTIONS PRIOR TO THE TIME OF CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R