BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 2495523 · Received March 19, 2012

    Report

    Report Number
    3008382007-2012-00915
    Event Type
    Injury
    Date Received
    March 19, 2012
    Date of Event
    February 18, 2012
    Report Date
    February 21, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2012 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE METER HAS ALSO BEEN RETURNED TO LFS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A FOLLOW UP REPORT WILL BE SUBMITTED. THE 510(K)# IS K110637.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HIS ONETOUCH VERIO IQ METER DOES NOT TURN ON. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY A CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL. THE PATIENT TESTS HIS BLOOD GLUCOSE FOUR TIMES A DAY (AT 6:30AM, 11:30AM, 5:30PM, AND 9:30PM) AND MANAGES HIS DIABETES WITH HUMALOG THREE TIMES A DAY (AFTER EACH TEST) AND LEVIMIR BEFORE BEDTIME; THE PATIENT INDICATED HIS INSULIN AMOUNT IS BASED ACCORDING TO HIS BLOOD GLUCOSE READING. THE PATIENT'S PRIMARY METER IS THE ONETOUCH VERIO IQ AND HIS SECONDARY/ BACK-UP METER IS HE ONETOUCH ULTRA2 METER (WHICH THE PATIENT REPORTEDLY KEEPS AT HOME). THE ALLEGED POWER ISSUE REPORTEDLY BEGAN SOMETIME BETWEEN 11:30AM AND 12PM ON (B)(6) 2012. APPROXIMATELY, FIVE HOURS PRIOR TO THE START OF THE ALLEGED POWER ISSUE, THE PATIENT INDICATED HE OBTAINED A BLOOD GLUCOSE READING OF "6.9MMOL/L" WITH THE SUBJECT METER; HOWEVER, IT IS NOT KNOWN WHAT ACTION THE PATIENT TOOK IN RESPONSE TO HIS READING. IMMEDIATELY AFTER THE REPORTED POWER ISSUE OCCURRED, THE PATIENT CLAIMED HE ATTEMPTED TO CHARGE THE SUBJECT METER; HOWEVER, "NOTHING WORKED". IN RESPONSE TO THE ALLEGED POWER ISSUE, THE PATIENT REPORTEDLY SKIPPED HIS 11:30AM INJECTION, CONSUMED HIS LUNCH, AND LATER DID MORE EXERCISE THAN USUAL. ACCORDING TO THE PATIENT, SINCE THE ALLEGED POWER ISSUE OCCURRED WHILE AWAY FROM HOME, HE WAS NOT ABLE TO TEST WITH HIS BACK-UP METER. AT APPROXIMATELY 3PM THAT DAY, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF THIRST AND SWEATING (SYMPTOMS THE PATIENT CORRELATED WITH LOW BLOOD GLUCOSE). AFTER THE ONSET OF HIS SYMPTOMS, THE PATIENT INDICATED HE ADMINISTERED SELF-TREATMENT BY CONSUMING UNSPECIFIED AMOUNTS OF JELLY BEANS AND GLUCOSE TABLETS; THE PATIENT REPORTEDLY FELT BETTER APPROXIMATELY 15 TO 20 MINUTES LATER. ACCORDING TO THE PATIENT, AT APPROXIMATELY 5:30PM, THE PATIENT RETURNED HOME AND BEGAN TO FEEL SIMILAR SYMPTOMS AS EARLIER. THE PATIENT REPORTEDLY OBTAINED A READING OF "3.8MMOL/L" WITH HIS BACK-UP METER AND AGAIN CONSUMED JELLY BEANS AS SELF-TREATMENT. LATER THAT DAY (TIME UNSPECIFIED), THE PATIENT INDICATED HE WAS ABLE TO SUCCESSFULLY CHARGE THE SUBJECT METER. THE PATIENT CLAIMS HE EXPERIENCED THE SYMPTOMS AGAIN (AT 5:30PM), BECAUSE HE WAS NOT ABLE TO TEST HIS BLOOD GLUCOSE WITH THE SUBJECT METER, SKIPPED HIS 11:30AM REGIMEN, MAY NOT HAVE CONSUMED ENOUGH "CARBS" DURING LUNCH, AND HAD AN INCREASE ACTIVITY LEVEL THAT DAY. DURING TROUBLESHOOTING, THE CSR NOTED THERE WAS NO MISUSE OF THE LFS PRODUCT, THE PATIENT WAS USING THE CORRECT TEST STRIPS, AND THE SUBJECT METER POWERS ON BOTH MANUALLY AND WITH THE TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3205320

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening| R