BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2870226 · Received December 12, 2012

    Report

    Report Number
    2531779-2012-14434
    Event Type
    Injury
    Date Received
    December 12, 2012
    Report Date
    November 14, 2012
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE DAILY INSULIN DELIVERY TOTALS WERE FOUND TO CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. THE ALARM HISTORY SHOWED NO ERRORS OR ALARMS ASSOCIATED TO THE COMPLAINT. THE PUMP WAS TESTED ON A 29 HOUR FLOW TEST AND THE PUMP PASSED THE REQUIRED TEST AND WAS FOUND TO BE DELIVERING WITHIN THE SPECIFICATIONS. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT DURING THE INVESTIGATION. THERE WAS NO DEFECT FOUND. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT'S MOM/REPORTER CONTACTED ANIMAS TO REPORT THAT THE PATIENT'S BLOOD GLUCOSE HAS BEEN ELEVATED AS HIGH AS 551 MG/DL WHILE SHE HAS BEEN ON INSULIN PUMP TREATMENT. ON THE DAY OF THE CALL TO ANIMAS, HER BLOOD GLUCOSE WAS IN THE HIGH 400 MG/DL. SHE DID NOT HAVE ANY KETONES AND DID NOT HAVE ANY SYMPTOMS OF NAUSEA OR VOMITING AT THE TIME OF CONCERN. LATER WHEN THE PATIENT CHANGED THE INFUSION SITE, IT WAS DISCOVERED THE PATIENT HAD A BENT CANNULA. AT THE TIME OF CONCERN, HER BLOOD GLUCOSE WAS AT 459 MG/DL. THE REPORTER GAVE THE PATIENT CORRECTION INSULIN VIA SYRINGE. THE PATIENT'S BLOOD GLUCOSE WAS LOWERED TO 300 MG/DL. WHEN THE PATIENT WAS PUT BACK ON THE INSULIN PUMP, HER BLOOD GLUCOSE ELEVATED TO 551 MG/DL. THE PATIENT FELT OK AND DID NOT HAVE ANY KETONES OR SYMPTOMS AT THE TIME OF CONCERN. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE CONCLUDED THERE WAS NO PUMP MALFUNCTION ASSOCIATED WITH THE ALLEGED EVENT. THE ADVANCE FEATURES AND THE BASAL SEGMENT ARE CORRECTLY PROGRAMMED ACCORDING TO THE PATIENT'S USAGE AT THE TIME OF THE EVENT. THE DATE AND TIME WAS CONFIRMED TO BE ACCURATE. THE PUMP DELIVERED INSULIN ACCORDINGLY AND NO INACCURATE DELIVERY ISSUE WAS FOUND. THERE WAS NO PRODUCT MISUSED. THE PATIENT REPORTEDLY HAD A BOLUS RECORDED FOUND IN THE PRIME HISTORY. FURTHER INVESTIGATION INTO OTHER FACTORS THAT COULD CONTRIBUTE TO THE ALLEGED EVENT REVEALED THE PATIENT IS GOING THROUGH PUBERTY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD ELEVATED BLOOD GLUCOSE ABOVE 500 MG/DL WHILE ON INSULIN PUMP THERAPY. IT IS NOT CLEAR WHETHER DIABETES MANAGEMENT, USE ERROR, OR INTENTIONAL MISUSE CONTRIBUTING TO THE ALLEGED EVENT. HENCE, THE EVENT IS BEING REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening