BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3092500 · Received May 3, 2013

    Report

    Report Number
    3008382007-2013-10076
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 6, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    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'S DAUGHTER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA2 METER READ INACCURATELY COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING A FOLLOW-UP CALL WITH THE REPORTER ON (B)(6) 2013, IN ADDITION TO THE CONVERSATION THE REPORTER HAD WITH THE CUSTOMER CARE ADVOCATE (CCA) ON (B)(6) 2013. THE REPORTER INFORMED THE CCA THAT ON (B)(6) 2013, A VISITING NURSE TOLD THE PATIENT THAT THE SUBJECT METER WAS READING INACCURATELY. THE PATIENT'S BLOOD GLUCOSE (BG) WAS TESTED WITH BOTH THE SUBJECT METER AND ANOTHER DEVICE; HOWEVER, THE REPORTER DID NOT KNOW THE READINGS OBTAINED ON EITHER OF THE DEVICES. THE REPORTER STATED THAT THE PATIENT WAS ADMINISTERING "TOO MUCH INSULIN" DUE TO THE SUBJECT METER READING INACCURATELY. DURING THE FOLLOW-UP CALL, THE REPORTER INFORMED THE MSS THAT ON THE MORNING OF (B)(6) 2013, THE PATIENT SUFFERED A LOW BG EXCURSION. THE REPORTER WAS TOLD THAT THE PATIENT WAS INCOHERENT AND WHEN THE PATIENT WAS TESTED WITH THE SUBJECT METER IN RESPONSE TO HIS CONDITION A BG OF "40 MG/DL RANGE" WAS OBTAINED. EMS WAS THEN CALLED. WHEN EMS ARRIVED, THE PATIENT'S BG WAS TESTED WITH AN EMS METER (RESULT NOT KNOWN) AND THE PATIENT WAS ADMINISTERED A GLUCAGON INJECTION. THE REPORTER CLAIMED SHORTLY AFTER RECEIVING THE INJECTION, THE PATIENT "CAME AROUND." THE PATIENT WAS TAKEN TO THE ER AND KEPT OVERNIGHT FOR OBSERVATION. THE REPORTER DID NOT KNOW WHAT THE PATIENT'S BG REGISTERED WHEN HE ARRIVED TO THE ER OR DID NOT KNOW WHAT ADDITIONAL TREATMENT, IF ANY, HE RECEIVED. PRIOR TO THE ONSET OF SYMPTOMS, THE PATIENT'S DAUGHTER REPORTED THAT THE PATIENT HAD TESTED ON THE EVENING OF (B)(6) 2013 AND HAD OBTAINED AN ELEVATED RESULT IN THE "300 TO 400 MG/DL" RANGE. THE REPORTER INFORMED THE MSS THAT THE PATIENT'S NORMAL/TYPICAL EVENING READINGS WERE IN THE "190-200 MG/DL RANGE." THE PATIENT WAS MANAGING HIS DIABETES A COMBINATION OF ORAL MEDICATION(S) AND INSULIN (DOSE BASED ON SLIDING SCALE). IN RESPONSE TO THE ELEVATED BG, THE PATIENT REPORTEDLY ADJUSTED HIS INSULIN DOSE (AMOUNT NOT KNOWN). REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. DURING THE FOLLOW-UP CALL, THE PATIENT'S DAUGHTER INFORMED THE MSS THAT THE PATIENT PASSED AWAY ON THE MORNING OF (B)(6) 2013. THE REPORTER CLAIMED SHE DID NOT HAVE A DEATH CERTIFICATE BUT MENTIONED CAUSE OF DEATH WAS A HEART ATTACK. THE REPORTER CONFIRMED AN AUTOPSY WAS NOT PERFORMED ON THE PATIENT. THE REPORTER INFORMED THE MSS THAT SHE DID NOT BELIEVE THAT A PRODUCT ISSUE WITH THE SUBJECT METER WAS RESPONSIBLE FOR THE PATIENT'S DEATH. THE PATIENT'S DAUGHTER STATED THAT ON THE MORNING OF (B)(6) 2012, THE PATIENT'S SPOUSE CALLED 911 WHEN THE PATIENT WAS FOUND UNRESPONSIVE. THE REPORTER STATED THAT THE PARAMEDICS WERE UNABLE TO REVIVE THE PATIENT AND WAS PRONOUNCED DEAD. THE REPORTER INFORMED THE MSS THAT THE PATIENT WAS DIAGNOSED WITH CONGESTIVE HEART FAILURE 7 OR 8 YEARS AGO AND WAS TAKING MEDICATIONS FOR HIS HEART, IN ADDITION TO TAKING MEDICATIONS FOR HIGH BLOOD PRESSURE AND FOR A PROSTATE CONDITION. THE REPORTER INFORMED THE MSS THAT THE AFTER THE PATIENT'S LOW BG EXCURSION ON (B)(6) 2013, HIS BG LEVELS WERE "GOOD." THE PATIENT'S SPOUSE REPORTED THAT THE PATIENT'S BG HAD REGISTERED BELOW "120 MG/DL" ON THE EVENING PRIOR TO HIS DEATH. THE PATIENT'S DAUGHTER ALSO CONFIRMED THAT THE PATIENT WAS NOT EXPERIENCING ANY SYMPTOMS OR COMPLAINING OF ANY HEALTH ISSUES ON THE EVENING OF (B)(6) 2013. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMED THE PATIENT OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY WAS TREATED FOR SEVERE HYPOGLYCEMIA BY AN HCP AFTER THE ALLEGED METER ISSUE BEGAN. HOWEVER, THERE IS NO EVIDENCE THAT THE LFS DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. PER THE REPORTER, THE PATIENT DIED FROM A HEART ATTACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193709 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3419126

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R