BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 4043452 · Received August 28, 2014

    Report

    Report Number
    2939301-2014-22091
    Event Type
    Injury
    Date Received
    August 28, 2014
    Report Date
    August 13, 2014
    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
    ME, 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) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) THAT HER ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE PATIENT BY PHONE TO OBTAIN ADDITIONAL INFORMATION. THE MSS LISTENED TO THE CALL RECORDING TO ASSIST IN CLASSIFYING THE COMPLAINT. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY STARTED A FEW WEEKS PRIOR TO CONTACTING LFS. THE PATIENT CLAIMED SHE WAS OBTAINING INACCURATE HIGH READINGS BETWEEN ¿219 AND 284 MG/DL¿ WITH THE SUBJECT METER, WHICH WERE HIGHER THAN EXPECTED. THE PATIENT INFORMED THE CCA THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATION; HOWEVER, IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ELEVATED RESULTS. THE PATIENT REPORTED DEVELOPING THE SYMPTOM OF ¿SWEATY¿ ON AN UNSPECIFIED DATE/TIME AFTER THE ALLEGED METER INACCURACY ISSUE BEGAN. IT IS NOT KNOWN IF THE PATIENT ASSOCIATED THE SYMPTOM WITH A HIGH OR LOW BLOOD GLUCOSE EXCURSION. NOR IS IT KNOWN WHAT MEDICAL TREATMENT, IF ANY, SHE RECEIVED IN RESPONSE TO THE SYMPTOM. THE PATIENT CLAIMED SHE SCHEDULED A DOCTOR¿S OFFICE VISIT DUE TO THE HIGH READINGS SHE WAS OBTAINING WITH THE SUBJECT METER. THE PATIENT STATED SHE SAW HER HCP ON THE AFTERNOON OF (B)(6) 2014. DURING THE DOCTOR¿S OFFICE VISIT, THE PATIENT REPORTED HER BLOOD GLUCOSE WAS CHECKED WITH HER HCP¿S METER AND THE RESULT WAS ¿122 MG/DL.¿ THE PATIENT CONFIRMED SHE DID NOT RECEIVE ANY FORM OF MEDICAL TREATMENT BY HER HCP DURING DOCTOR¿S OFFICE VISIT. SHE WAS ADVISED BY HER HCP TO GET A NEW METER. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER AND STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER INACCURACY BEGAN. THE LFS PRODUCT COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525611 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3584867

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening