BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3082116 · Received April 29, 2013

    Report

    Report Number
    3008382007-2013-09378
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 6, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED OBTAINING AN ALLEGED INACCURATE HIGH READING OF "457 MG/DL" WITH THE SUBJECT METER ON THE AFTERNOON OF (B)(6) 2013. THE PATIENT INFIRMED THE CCA THAT HE MANAGES HIS DIABETES WITH A COMBINATION OF INSULIN AND ORAL MEDICATION. THE PATIENT CLAIMED HE TOOK HIS USUAL DOSE OF MEDICATION DESPITE THE HIGHER THAN EXPECTED READING; HOWEVER, APPROXIMATELY 10-15 MINUTES LATER, CLAIMED HE DEVELOPED SYMPTOMS OF "SWEATING, SHAKY, FATIGUE, DIZZINESS AND NAUSEA." THE PATIENT REPORTED TREATING SELF WITH GLUCOSE TABLETS/GEL. AT THE TIME OF THE CALL, THE PATIENT ALSO REPORTED THAT ON THE MORNING OF (B)(6) 2013, HE HAD DEVELOPED SYMPTOMS OF "VERY SWEATY, BLURRY VISION AND SHAKY." AT THE ONSET OF SYMPTOMS HE TESTED WITH THE SUBJECT METER AND OBTAINED AN ALLEGED INACCURATE LOW READING OF "70 MG/DL" WITH THE SUBJECT METER. THE PATIENT REPORTED TREATING SELF WITH FOOD AND/OR DRINK. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER AND TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER OBTAINING AN ALLEGED INACCURATE HIGH READING WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183968 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3285239

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R