BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3243556 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11772
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 07/10/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/03/2014 WITH THE FOLLOWING FINDINGS: THE LAST BASAL DELIVERY WAS ON 04/12/2013@1:43PM, NO ACTIVITY OUTSIDE OF NORMAL USE IS OBSERVED. INVESTIGATORS WERE UNABLE TO VERIFY STEPS AND TO ADEQUATELY INVESTIGATE THE REPORTED COMPLAINT DUE THE PUMP DISASSEMBLY. 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 HE HAD BLOOD GLUCOSE EXCURSIONS IN THE 600 MG/DL RANGE AND IN THE 40 MG/DL RANGE MANY TIMES SINCE HE HAD BEEN OFF THE PUMP. THE PATIENT WENT OFF OF INSULIN PUMP THERAPY AFTER SHE RECEIVED REPEATED CALL SERVICE ALARMS. ACCORDING TO THE PATIENT, HE IS NOT ABLE TO MANAGE HIS DIABETES SO WELL WHILE HE IS TAKING INSULIN VIA SYRINGE. HE HAS SYMPTOMS DESCRIBED AS ¿AGITATED, COMBATIVE, AND HAS HOT FLASHES AND SWEATS¿ WHEN HE HAS LOW OR HIGH BLOOD GLUCOSE. HE REPORTEDLY SPENT LAST NIGHT TAKING MULTIPLE INSULIN SHOTS BECAUSE HE WAS UNSURE WHETHER HE TOOK 8 UNITS OF SHORT ACTING INSULIN OR LANTUS. THE PATIENT RECEIVED A REPLACEMENT PUMP ON THE DAY OF THE CALL TO ANIMAS AND REPORTEDLY WILL GO TO THE DOCTOR¿S DOCTOR TO SETUP HIS NEW PUMP AND TO DISCUSS HOW TO USE THE PUMP WITHOUT FURTHER ALARMS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD BLOOD GLUCOSE EXCURSIONS WHILE HE WAS OFF OF INSULIN PUMP THERAPY DUE TO CALL SERVICE ALARM ISSUES AND WAS ON THE BACKUP PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342603 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR