BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1051824 · Received May 23, 2008

    Report

    Report Number
    2939301-2008-00913
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 27, 2008
    Report Date
    April 30, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    IN 2008, THE LAY USER/REPORTER CONTACTED LIFESCAN ON BEHALF OF THE LAY USER/PT ALLEGING THE ONE TOUCH ULTRA METER WAS SHOWING THE PREVIOUS READINGS WHEN THE PT WAS TAKING A BLOOD TEST. THE MEDICAL AFFAIRS SPECIALIST CONTACTED THE REPORTER TO OBTAIN/CLARIFY INFO. STARTING AROUND APRIL 20, THE PT'S HOME NURSE WAS UNABLE TO TEST ON THE METER DUE TO THE ISSUE. BOTH THE PT AND THE PT'S HOME NURSE USE THE METER TO TEST. THE REPORTER STATED THAT THREE DAYS PRIOR TO ORIGINAL DATE IN THE MORNING, SHE FOUND HER MOTHER (THE PT) UNCONSCIOUS IN HER BEDROOM. SHE DECIDED TO CALL EMERGENCY SERVICES AT THIS TIME, AND THEY ARRIVED ABOUT 5 MINUTES LATER. WHEN EMERGENCY SERVICES GOT THERE, THEY TESTED HER MOTHER AND OBTAINED A RESULT OF 42 MG/DL. THEY INJECTED HER WITH AN UNK SUBSTANCE AND SHE REGAINED CONSCIOUSNESS IN 5 MINUTES. SHE WAS ABLE TO SPEAK WHEN SHE REGAINED CONSCIOUSNESS. AT 10 TO 15 MINUTES AFTER THEY ARRIVED, THE PARAMEDICS DECIDED TO TAKE THE PT TO THE HOSPITAL WHERE THEY FURTHER MONITORED HER CONDITION, BUT THE REPORTER DOUBTS SHE RECEIVED ANY ADD'L TREATMENT. SHE STAYED AT THE HOSPITAL UNTIL 2 PM THAT AFTERNOON. BEFORE EVENT DATE, THE PT TOOK 850 MG OF GLUCOPHAGE IN THE MORNING AND THE EVENING. SHE ALSO TOOK 1 PILL OF AMARYL IN THE MORNING AND EVENING. THE DOCTOR AT THE HOSPITAL RECOMMENDED DISCONTINUING AMARYL. SINCE THEN, THE PT HAS VISITED ANOTHER PHYSICIAN WHO RECOMMENDED THAT SHE HALVE HER DOSE OF AMARYL TO 1/2 OF A PILL IN THE MORNING AND THE EVENING (RATHER THAN DISCONTINUE IT), AND TAKE 1000 MG OF GLUCOPHAGE IN THE MORNING AND THE EVENING. SHE CURRENTLY TAKES THE DOSE RECOMMENDED BY HER CANCER PHYSICIAN. THE REPORTER DOES NOT KNOW WHETHER THE PT WOULD HAVE CHANGED ANY HABITS BASED ON METER READINGS HAD SHE BEEN ABLE TO TEST BECAUSE SHE DOES NOT NORMALLY ADJUST ANY HABITS BASED ON READINGS. SHE USES THE READINGS TO GENERALLY MONITOR HER BLOOD SUGAR. THE REPORTER DOES NOT KNOW WHETHER THE PT ATE ANY LESS OR MORE WHEN SHE EXPERIENCED SYMPTOMS. THE REPORTER STATES THE PT HAS NEVER FALLEN UNCONSCIOUS, DUE TO LOW BLOOD SUGAR BEFORE THIS INSTANCE. PRIOR TO (A WEEK PRIOR TO EVENT DATE), THE PT CLAIMED THAT SHE DID NOT EXPERIENCE ANY SYMPTOMS. THE METER ISSUE WAS RESOLVED BY TRAINING THE CUSTOMER DURING THE TROUBLESHOOTING TELEPHONE CALL. THIS COMPLAINT IS BEING REPORTED BECAUSE IT WAS ALLEGED THAT THE PT WAS NOT ABLE TO OBTAIN READINGS FOR APPROX ONE WEEK AND EXPERIENCED SYMPTOMS INDICATIVE OF HYPERGLYCEMIA AFTER THE REPORTED ISSUE. ALTHOUGH THE PT DOES NOT NORMALLY CHANGE ANY TREATMENT HABITS BASED ON METER READINGS, IT IS UNK WHETHER SHE MAY HAVE HAD IN THIS INSTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2560612

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Hospitalization| L| R