BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3222604 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10431
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/25/2013 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE PUMP HISTORY INDICATED THAT THE LAST BOLUS AND BASAL DELIVERED WAS ON (B)(6) 2013 .A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. ONLY TYPICAL USAGE ALARMS AND WARNINGS WERE OBSERVED IN THE ALARM HISTORY. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE DISCOLORED WITH A PINKISH CONTRAST. A NEW TEST SCREEN WAS INSERTED AND THE DISPLAY SCREEN ILLUMINATED TO NORMAL CONTRAST. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY-USER/PATIENT CONTACTED ANIMAS TO REPORT SHE HAD A LOW BLOOD GLUCOSE READING WHICH CAUSE A VISION DISTURBANCE. SHE REPORTEDLY HAD TO HAVE HER SON DRIVE THE CAR. THE PATIENT COULD NOT PROVIDE ANY NUMERIC VALUES BECAUSE SHE DID NOT CHECK HER BLOOD GLUCOSE AT THE TIME OF CONCERN. THE PATIENT CLAIMED SHE HAD BEEN HAVING LOW BLOOD GLUCOSE VERY DAY AFTER LUNCH FOR THE LAST MONTH. THE PATIENT TOOK FAST CARBOHYDRATE AND FELT BETTER WITHIN 30 MINUTES. ONE OF THE CONTRIBUTORS TO HER BLOOD GLUCOSE EXCURSIONS REPORTEDLY WAS HER MENOPAUSE WITH INCREASE HOT FLASHES/SWEATS AND THEN COLD SPELLS. THE PATIENT WAS ADVISED TO CONTACT HER HEALTHCARE PROVIDER TO ADJUST HER INSULIN REGIMEN ACCORDINGLY WHILE SHE WAS IN A STATE OF MENOPAUSE. THE PATIENT HAS CONTINUED ON INSULIN PUMP THERAPY. AT THE TIME OF THE PHONE CALL TO ANIMAS, HER BLOOD GLUCOSE WAS ABOVE 70 MG/DL. TROUBLESHOOTING INDICATED THERE WAS NO EVIDENCE OF A PRODUCT MALFUNCTION. THE ADVANCE FEATURES AND THE BASAL SEGMENT ARE CORRECTLY PROGRAMMED ACCORDING TO THE PATIENT¿S USAGE. THE DATE AND TIME WAS CONFIRMED TO BE ACCURATE. THERE WAS NO PRODUCT MISUSE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE HAD LOW BLOOD GLUCOSE WITH SYMPTOM THAT CAN BE SUGGESTIVE OF A SERIOUS INJURY WHILE ON INSULIN PUMP THERAPY. ALTHOUGH THERE WAS NO EVIDENCE OF A PRODUCT MALFUNCTION, THE ANIMAS PRODUCT COULD NOT BE RULED OUT AS A CONTRIBUTOR OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322400 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening