BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO TEST STRIPS

    MDR report key: 2945614 · Received February 6, 2013

    Report

    Report Number
    3008382007-2013-02331
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    February 4, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER AND TEST STRIPS PASSED ALL TESTING. THE PRIMARY ISSUE COULD NOT BE REPRODUCED. UNRELATED, THE SUBJECT TEST STRIP HAD AN ERROR 4 ISSUE. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. DEVICE RETURNED TO MFG DATE: METER- 3/4/2013, TEST STRIPS- 2/19/2013. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HIS ONETOUCH VERIO IQ METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY A CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN AT AN UNKNOWN DATE/TIME APPROXIMATELY 1 WEEK AGO. HE TESTED AT AN UNKNOWN TIME IN THE MORNING AND OBSERVED WHAT HE THOUGHT AS A "NORMAL RESULT" OF "5.8 MMOL/L". THE PATIENT INFORMED THE CSR THAT HE TESTS 4 TIMES PER DAY; WITH BREAKFAST, LUNCH, SUPPER AND PRIOR TO GOING TO SLEEP AND MANAGES HIS DIABETES WITH HUMALOG INSULIN 28 UNITS IN THE MORNING, AT LUNCH AND IN THE EVENING AND IN ADDITION TO LANTUS - 32 UNITS BEFORE BEDTIME. THE PATIENT DENIED MAKING ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE AND THUS TOOK HIS MORNING DOSE OF INSULIN AS USUAL. THE PATIENT CLAIMED THAT SOMETIME AFTER TESTING THAT SAME MORNING HE WAS "FEELING LOW" BUT COULD NOT SPECIFY ANY ASSOCIATED SYMPTOMS. HE STATED HE SELF TREATED BY DRINKING HALF A GLASS OF ORANGE JUICE AND SOME FOOD; HE STATED THIS IS WHAT HE USUALLY CONSUMES WHENEVER HE "FEELS LOW". THE PATIENT CLAIMED THAT A SHORT TIME AFTERWARDS ON THAT SAME MORNING, HE HAD PASSED OUT. HIS ROOMMATE CONTACTED THE EMERGENCY MEDICAL SERVICES (EMS) AND WHEN THEY ARRIVED, THEY ADMINISTERED A GLUCAGON SHOT AND TOOK HIM TO THE HOSPITAL. WHEN THE PATIENT ARRIVED AT THE HOSPITAL HE WAS TESTED ON A HOSPITAL METER AND A READING OF "2.1 MMOL/L" (38 MG/DL) WAS OBSERVED. THE PATIENT STATED HE WAS ALSO TREATED AT THE HOSPITAL WITH FOOD AND DRINK. HE WAS RETESTED A FEW HOURS LATER AND A RESULT OF "7.1 MMOL/L" (127 MG/DL) WAS OBSERVED; THE SAME RESULT WAS OBTAINED ALSO ABOUT ONE HOUR LATER, PER THE PATIENT. THE PATIENT WAS RELEASED FROM HOSPITAL ON THE SAME DAY. THE PATIENT SUSPECTED THAT THE METER RESULT OBTAINED EARLIER AT HOME WAS INACCURATELY HIGH. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE TEST STRIPS WERE IN GOOD CONDITION, A CONTROL SOLUTION TEST WAS NOT PERFORMED BECAUSE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED HIS USUAL INSULIN DOSE, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA THAT REQUIRED TREATMENT FROM AN HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50591 OT VERIO TEST STRIPS GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3387591

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R