BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1821695 · Received August 31, 2010

    Report

    Report Number
    2939301-2010-07408
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 5, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LAY USER/PATIENT'S TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRAMINI METER IS GIVING INACCURATE ERRATIC READINGS OF "133 AND 144 MG/DL." THIS MEDICAL SURVEILLANCE SPECIALIST CONTACTED THE PATIENT ON AUGUST 31, 2010 TO CLARIFY INFORMATION OBTAINED DURING THE INITIAL PHONE CALL. THE PATIENT'S DIABETES IS MANAGED WITH LANTUS INSULIN AND METFORMIN ORAL MEDICATION. THE PATIENT TESTS HER BLOOD GLUCOSE 3 OR 4 TIMES PER DAY. ON (B)(6) 2010 AT 11 AM, THE PATIENT REPORTEDLY OBTAINED INACCURATE HIGH READING OF "200 MG/DL." AS A RESULT OF THE ALLEGED HIGH READING, THE PATIENT DRANK COFFEE, SKIPPED HER METFORMIN MEDICATION, AND DID NOT EAT HER USUAL BREAKFAST. AT 30 MINUTES LATER, WHILE THE PATIENT WAS GROCERY SHOPPING, SHE DEVELOPED SYMPTOM OF FEELING LIGHTHEADED AND "WENT DOWN." THE PATIENT CLAIMED THAT SHE DID NOT PASS OUT BUT FELL TO THE FLOOR AND REQUIRED THE ASSISTANCE OF THE TWO MARKET EMPLOYEES. THE PATIENT WAS GIVEN ORANGE JUICE AT THE TIME OF CONCERN. HER SYMPTOMS ABATED SHORTLY AFTER AND DID NOT REQUIRE ANY FURTHER MEDICAL TREATMENT. LATER, WHEN THE PATIENT ARRIVED HOME, THE PATIENT REPORTEDLY WAS STILL TESTING IN THE "200 MG/DL" RANGE ON THE SUBJECT METER WHICH THE PATIENT FELT WAS INACCURATELY HIGH. ACCORDING TO THE PATIENT, HAD SHE OBTAINED READINGS LOWER THAN 200 MG/DL ON THE SUBJECT METER THAT MORNING, SHE WOULD HAVE EATEN MORE AND MAY HAVE PREVENTED THE EPISODE ON THE GROCERY STORE. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, READINGS OF "133 AND 144 MG/DL" WERE PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS IS WITHIN THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPOGLYCEMIA AND RECEIVED MEDICAL INTERVENTION WITH THE ASSISTANCE OF ANOTHER PERSON.

    Description of Event or Problem · 1

    AN ADC CUSTOMER REPORTED THAT DUE TO USING FS CLASSIC STRIPS WITH THEIR FS LITE METER, THEY RECEIVED ERRATIC READINGS AND EXPERIENCED AN INJURY. THE CUSTOMER SPECIFICALLY REPORTED THAT DUE TO THE READINGS ISSUE SHE WAS DETAINED BY POLICE OFFICERS AND HELD UNTIL HER HUSBAND PICKED HER UP AS THE OFFICERS "THOUGHT" SHE "WAS DRUNK BECAUSE (HER) GLUCOSE WAS LOW." DURING THE CALL WITH CUSTOMER SERVICE, THE CUSTOMER BECAME FRUSTRATED AND REFUSED TO ANSWER ANY ADDITIONAL QUESTIONS AND DISCONNECTED THE CALL. NO LOSS OF CONSCIOUSNESS OR SEIZURE WAS REPORTED. THE DATE/TIME OF THE MEDICAL EVENT AND PRODUCT ISSUE WAS NOT REPORTED AND NO SPECIFIC READINGS WERE PROVIDED BY THE CUSTOMER. ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO COMPLETE THE SURVEYS AND ACQUIRE THE MISSING INFORMATION. A SUCCESSFUL FIELD EXCHANGE FOR THE CORRECT TEST STRIPS WAS PROVIDED FOR THE CUSTOMER. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS CASE.

    Description of Event or Problem · 1

    ON (B)(6) 2010, RECEIVED INFUSION DEVICE FROM PT. ON (B)(6) 2010, PT PREVIOUSLY REPORTED BEING HOSPITALIZED DUE TO ELEVATED BLOOD GLUCOSE AND HIS INFUSION DEVICE (2) STOPPED WORKING AND HE DIDN'T KNOW WHY. PT STATED AT THAT TIME THAT HE WAS UNSURE OF WHICH INFUSION DEVICES HE HAD AND WAS UNABLE TO LOCATE THEM. ON CALL BACK FROM PT ON (B)(6) 2010, PT REPORTED HE WAS NOT ABLE TO PIN POINT THE ISSUE HE WAS HAVING WITH THE INFUSION DEVICE. PT STATED HE WAS NOT RECEIVING ANY INSULIN FROM THE INFUSION DEVICE. PT REPORTED THE DATE OF THE HOSPITALIZATION HE FELT AWFUL AND WAS UNABLE TO KEEP ANY FOOD DOWN. HE STATED HE WENT TO THE HOSPITAL AND THEY TESTED HIS BLOOD GLUCOSE AT 915 MG/DL AND ADMITTED HIM OVERNIGHT. PT REPORTED HE DID NOT RECEIVE ANY OCCLUSIONS WARNINGS AND PRIOR TO GOING TO THE HOSPITAL; THE INFUSION DEVICE WAS WORKING FINE BECAUSE HE WAS HAVING READINGS AROUND 150 MG/DL WHICH IS ABOUT NORMAL FOR HIM. PT STATED HE WAS EXPERIENCING THE ELEVATED READINGS FOR A 24 HOUR PERIOD. INFUSION DEVICE IS NOT AVAILABLE FOR TROUBLESHOOTING. PT REPORTED HE WAS USING HIS PRIMARY INFUSION DEVICE AT THE TIME OF THE INCIDENT AND ATTEMPTED TO USE HIS BACKUP INFUSION DEVICE WHEN HE RETURNED FROM THE HOSPITAL BUT HIS READINGS REMAINED ELEVATED AS IF HE STILL WASN'T RECEIVING ANY INSULIN. REPLACEMENT PRODUCT WAS SENT; INFUSION DEVICE WAS ALREADY RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT MDS LIFESCAN INC. 3004750

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R