BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA MINI METER

    MDR report key: 9389527 · Received November 28, 2019

    Report

    Report Number
    3008382007-2019-03825
    Event Type
    Injury
    Date Received
    November 28, 2019
    Date of Event
    November 9, 2019
    Report Date
    November 21, 2019
    Manufacturer
    LIFESCAN EUROPE GMBH
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT PROBLEM CODE FOR BLOCK. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH WHEN TESTING WITH CONTROL SOLUTION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE AGENT (CSA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE OCCURRED ON (B)(6) 2019 AT AROUND 2:30 PM. THE PATIENT REPORTED OBTAINING A CONTROL SOLUTION RESULT OF ¿298 MG/DL¿ WITH THE SUBJECT METER WHICH SHE COMPARED TO A CONTROL SOLUTION RESULT OF ¿178 MG/DL¿ ON ANOTHER DEVICE (FREESTYLE). THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH NOVOLOG INSULIN ADJUSTED BASED ON BLOOD GLUCOSE RESULTS (8 UNITS WHEN HER BLOOD GLUCOSE LEVEL IS BETWEEN 301-350 MG/DL, 6 UNITS BETWEEN 241-300 MG/DL, 4 UNITS BETWEEN 181-240 MG/DL AND 2 UNITS BETWEEN 131-180 MG/DL). THE PATIENT DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT AT AN UNSPECIFIED TIME ON (B)(6) 2019, AFTER THE ALLEGED ISSUE OCCURRED, SHE BECAME ¿SCARED, DIZZY, COULDN¿T STAND UP¿ AND HER ¿MOUTH WAS NUMB AND FINGERS TINGLING.¿ IN RESPONSE TO THE SYMPTOMS, THE PATIENT CLAIMED SHE WAS TAKEN TO HOSPITAL BY AMBULANCE. THE PATIENT STATED THAT SHE WAS TREATED WITH IV FLUIDS AND GLUCOSE GEL IN THE AMBULANCE AND THAT HER BLOOD GLUCOSE WAS MEASURED AT ¿71 MG/DL¿ ON ARRIVAL AT HOSPITAL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION FOR AN ACUTE LOW BLOOD GLUCOSE EXCURSION AFTER THE ALLEGED PRODUCT ISSUE BEGAN. THE SUBJECT METER COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182665 OT ULTRA MINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE GMBH 4554772

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R