BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1173442 · Received September 23, 2008

    Report

    Report Number
    2939301-2008-02367
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 18, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, 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

    THE LAY USER/PATIENT'S WIFE CONTACTED LIFESCAN IN 2008 AND ALLEGED A PRODUCT IMPROVEMENT/USABILITY ISSUE WITH THE PATIENT'S ONE TOUCH ULTRA METER. THE MEDICAL AFFAIRS SPECIALIST (MAS) CALLED AND SPOKE WITH THE WIFE AT ABOUT 4 DAYS LATER, AND OBTAINED ADDITIONAL INFO. THE WIFE REPORTED THAT THE PT WAS HAVING TROUBLE SETTING THE TIME ON THE SUBJECT METER ABOUT 4 DAYS PRIOR TO CALL. SHE MENTIONED THAT THEY "FORGOT TO SET THE TIME". THIS ISSUE WAS RESOLVED WITH TROUBLESHOOTING AND THE METER WAS "NOW KEEPING THE CORRECT TIME". SHE HAD ALSO INITIALLY REPORTED THAT THE PT HAD EXPERIENCED BEING HOT AND SWEATY AFTER THE REPORTED ISSUE. HOWEVER, WHEN THE MAS SPOKE WITH THE WIFE, SHE STATED THAT THE PT ACTUALLY TOOK "ADDITIONAL INSULIN" DUE TO A HIGH RESULT HE HAD OBTAINED AND LATER REPORTEDLY EXPERIENCED THE LOW SYMPTOMS. THE ALLEGED HIGH RESULT WAS 234 MG/DL AND WAS OBTAINED IN THE NEXT DAY (TIME NOT PROVIDED) AND BASED ON HIS SLIDING SCALE, HE TOOK 5 UNITS OF NOVALOG INSULIN. "A FEW MINUTES LATER", HE EXPERIENCED THE LOW SYMPTOMS AND THE WIFE GAVE HIM A "BOTTLE OF GLUCODRINK - LEMON/LIME FLAVOR". HE FELT BETTER AFTER THAT. DURING THE TIME HE WAS EXPERIENCING THE LOW SYMPTOMS, HE WAS TESTED ON THE SUBJECT METER AND HAD OBTAINED A RESULT OF 47 MG/DL. THE MAS CONFIRMED WITH THE WIFE THAT THE PT WAS STILL ABLE TO TEST HIS BLOOD GLUCOSE AT THE TIME HE WAS HAVING TROUBLE SETTING THE CORRECT TIME ON THE METER. HOWEVER, AFTER THE TIME ISSUE HAD BEGUN, HE OBTAINED AN ALLEGED HIGH RESULT AND EXPERIENCED LOW SYMPTOMS AFTER BASING ADDITIONAL INSULIN ON THAT RESULT. THE MAS CONFIRMED THAT THE METER WAS SET IN THE RIGHT UNIT OF MEASUREMENT (MG/DL), THE TEST STRIPS WERE IN GOOD CONDITION AND WITHIN THE EXPIRATION/DISCARD DATES, AND THE PATIENT'S TESTING TECHNIQUE WAS CORRECT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE WIFE ALLEGED THAT THE PT EXPERIENCED SYMPTOMS OF SUGGESTIVE OF HYPOGLYCEMIA AFTER HE WAS ADMINISTERED INSULIN BASED ON THE ALLEGED HIGH RESULT HE OBTAINED ON A SUBJECT METER. HE WAS REPORTEDLY TREATED FOR LOW BLOOD GLUCOSE AND FELT BETTER. THE ALLEGED ISSUE OF SETTING THE TIME WAS RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE LAY USER/PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2803215

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening