BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2112900 · Received June 3, 2011

    Report

    Report Number
    2531779-2011-03896
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 07/21/2011. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(6) 2011 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.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE DAILY INSULIN DELIVERY TOTALS SHOWED THAT THE PUMP WAS DELIVERING ACCURATELY UP UNTIL THE LAST DATE USED BY THE PATIENT. THE TOTAL DAILY DOSES WERE FOUND TO CORRECTLY REFLECT THE USER'S PROGRAMMED BASAL RATES. THE BLACK BOX FOR THE ORIGINAL COMPLAINT HAS BEEN OVERWRITTEN AND IS NO LONGER AVAILABLE FOR INVESTIGATION DUE TO CONTINUED PATIENT USE OF THE PUMP. THERE WERE NO ALARMS OR PUMP CONDITIONS REPRESENTING A MALFUNCTION RECORDED IN THE BLACK BOX OR ALARM HISTORY. A 29 HOUR FLOW TEST WAS PERFORMED ON THE RETURNED PUMP AND THE PUMP PASSED AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. THERE WERE N O INSULIN DELIVERY OR FUNCTIONAL DEFECTS FOUND WITH THE RETURNED PUMP.

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT HER BLOOD GLUCOSE HAS BEEN ELEVATED TO 400-500 RANGE SINCE (B)(6) 2011. REPORTEDLY, THE ELEVATED BLOOD GLUCOSE IS EXPECTED DUE TO THE ABILIFY MEDICATION SHE HAS BEEN TAKING FOR THE LAST 3 YEARS. HER HEALTHCARE PROVIDER RECENTLY INCREASED HER BASAL RATE TO COMPENSATE FOR THE ELEVATED BLOOD GLUCOSE. PRIOR TO CONTACTING ANIMAS, SHE DISCONTINUED THE ANIMAS PUMP TREATMENT PER THE RECOMMENDATION OF THE HCP AND ADMINISTERED 60 UNITS OF LANTUS INSULIN VIA SYRINGE. WITHIN 2 HOURS, HER BLOOD GLUCOSE LOWERED TO 346 MG/DL. THE PATIENT ALLEGEDLY HAD SYMPTOM OF NAUSEA AT THE TIME OF CONCERN. DURING TROUBLESHOOTING, THE ANIMAS CONFIRMED THE SETTING ON THE PUMP WAS CORRECT. THERE WAS NO EVIDENCE OF A PRODUCT MALFUNCTION. THE ANIMAS REPRESENTATIVE CONCLUDED THE HIGH BLOOD GLUCOSE MAY BE DUE TO EITHER SITE ISSUE, SCAR TISSUE, BENT CANNULAS, AND/OR MEDICAL ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE PATIENT ALLEGEDLY HAD ELEVATED BLOOD GLUCOSE WHILE SHE MANAGED HER BLOOD GLUCOSE WITH THE ANIMAS PUMP.

    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 61 YR Life Threatening| R