BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2220823 · Received August 23, 2011

    Report

    Report Number
    2939301-2011-07923
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 30, 2011
    Report Date
    August 1, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K061118.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LFS ALLEGING INACCURATE HIGH READINGS ON HIS ONE TOUCH ULTRAMINI METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE PATIENT AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT MENTIONED THAT ON (B)(6) 2011 AT 6PM, HE HAD TESTED HIS BLOOD GLUCOSE AND OBTAINED A 138 MG/DL AND TOOK HUMALOG INSULIN BASED ON THE METER READING. HE DOES NOT RECALL HOW MUCH INSULIN HE HAD TAKEN. HE ATE DINNER AND AT AROUND 10:35 PM, HE DEVELOPED SYMPTOMS OF BEING COMBATIVE, INCOHERENT AND PASSED OUT. A FAMILY MEMBER CONTACTED PARAMEDICS AND DID NOT ATTEMPT TO TEST OR TREAT THE PATIENT BEFORE THE PARAMEDICS ARRIVED. WHEN THE PARAMEDICS ARRIVED, THEY TESTED THE PATIENT AND OBTAINED A 29 MG/DL AND WHEN THEY TESTED THE PATIENT ON HIS METER THEY OBTAINED A 134 MG/DL. READINGS WERE LESS THAN 20 MINUTES FROM ONE ANOTHER. THE PATIENT WAS TREATED WITH IV GLUCOSE AND REGAINED CONSCIOUSNESS IN THE AMBULANCE. THE PATIENT WAS IN THE ER FOR 4 HOURS AND WAS TREATED WITH GLUCOSE AND CLAIMS THAT DUE TO THE ALLEGED ISSUE, HIS INSULIN WAS CHANGED AND NOW HE BASES HIS INSULIN ON CARBOHYDRATE COUNTING. HE DID NOT RECALL WHAT HIS READING WAS PRIOR TO LEAVING THE ER. THE TEST STRIPS THE PATIENT HAD BEEN USING WERE NOT EXPIRED AND WAS IN GOOD CONDITION. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE PRODUCTS WAS REPLACED AND REQUESTED BACK. THE PRODUCTS WERE RETURNED AND INVESTIGATED AND NO PROBLEMS WERE FOUND WITH THE METER OR THE SUBJECT TEST STRIPS. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE THE READING HE TOOK AN UNSPECIFIED AMOUNT OF INSULIN AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY BASED ON LFS DEFINITION AND HAD TO BE TREATED BY PARAMEDICS AND ADMITTED IN THE ER. THE METER READING ON THE LFS METER AND THE PARAMEDICS METER WAS GREATER THAN 30 MG/DL OR 30% FROM ONE ANOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3134188

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R