BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2840890 · Received November 20, 2012

    Report

    Report Number
    2531779-2012-13815
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    October 26, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILLED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS TO REPORT SEVERAL ISSUES. DURING THE CALL, THE PATIENT INFORMED CUSTOMER SUPPORT THAT 4 OR 5 WEEKS PRIOR HE HAD A SEVERE LOW BLOOD GLUCOSE (BG) EXCURSION. THE PATIENT CLAIMED ON THE DAY OF THE LOW BG EXCURSION HE HAD ATE BREAKFAST BUT DID NOT HAVE THE OPPORTUNITY TO EAT LUNCH PRIOR TO A 12:30 MEETING AT THIS JOB. THE PATIENT STATED THAT AT APPROXIMATELY 2PM HE BECAME CONFUSED AND SAT DOWN IN RESPONSE TO THE SYMPTOMS AND ATE TOMATOES. THE PATIENT INFORMED CUSTOMER SUPPORT THAT HE DROVE HIMSELF HOME, BUT ON WAY HOME HE STOPPED AT A FAST FOOD RESTAURANT TO PICK UP SOMETHING TO EAT. THE PATIENT STATED HE ATE, BUT HIS SON SUGGESTED HE GO TO THE ER. THE PATIENT'S SON DROVE THE PATIENT TO THE ER, WHERE HE WAS TOLD BY AN HCP THAT THEY THOUGHT HIS ONSET OF SYMPTOMS WERE AS A RESULT OF A LOW BG. THE PATIENT STATED BY THE TIME HE ARRIVED TO THE ER HIS BG WAS "OK". IT IS NOT KNOWN IF THE PATIENT HAD TESTED HIS BG AT ONSET OF SYMPTOMS OR PRIOR TO EATING. THE PATIENT INFORMED CUSTOMER SUPPORT THAT DURING ER VISIT THEY RAN BLOOD TESTS AND HE WAS PLACED ON AN IV AND MONITORED BUT LATER DISCHARGED. AT THE TIME OF THE CALL, CUSTOMER SUPPORT NOTED THAT THE PATIENT DID NOT WANT TO TROUBLESHOOT THE ALLEGED ISSUE. IT WAS NOTED THAT THE PUMP HAD BEEN EXPOSED TO X-RAY ABOUT 2 WEEKS AFTER THE PATIENT STARTED ON THE PUMP. DURING THE CALL, THE PATIENT MENTIONED THAT HE HAD MADE SOME CHANGES TO THE PUMP SETTINGS ON HIS OWN. NO ADDITIONAL INFORMATION WAS PROVIDED. DURING A FOLLOW-UP CALL TO THE PATIENT, IT WAS NOTED THAT THE PATIENT FELT THE LOW BG EXCURSION WAS AS A RESULT OF NOT EATING PROPERLY AND GETTING TOO MUCH INSULIN DUE TO SETTINGS IN THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA WHILE ON INSULIN PUMP THERAPY. BASED ON THE INFORMATION PROVIDED, THE PATIENT'S ALLEGED HYPOGLYCEMIA CAN BE ATTRIBUTED TO USE ERROR SINCE THE PATIENT CONTINUED TO USE THE PUMP AFTER EXPOSING IT TO X-RAY. THE OWNER'S BOOKLET INSTRUCTS THE USER AGAINST PUMP EXPOSURE TO X-RAYS. IN ADDITION, THE PATIENT REPORTED MAKING ADJUSTMENT TO THE PUMP SETTINGS ON HIS OWN ACCORD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening