BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3080743 · Received April 26, 2013

    Report

    Report Number
    2531779-2013-05383
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    March 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    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 BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION 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: DURING INVESTIGATION, THE PUMP¿S HISTORY WAS REVIEWED AND SHOWED THAT INFORMATION FROM THE REPORTED FAILURE DATE WAS OVERWRITTEN. THE REVIEW SHOWED NUMEROUS LOSS OF PRIME ALARMS DUE LOW NON-ZERO FORCE. NO INSULIN DELIVERY INTERRUPTION WAS OBSERVED. THE TOTAL DAILY DOSE ADDED UP CORRECTLY AND REVEALED THE USER¿S PROGRAMMED BASAL RATE TARGET. THE PUMP POWERED ON AND DISPLAYED THE VERIFY SCREEN. THE PUMP WAS PRIMED AND EXERCISED FOR 24 HOURS ON A 1 UNIT/HOUR BASAL PROGRAM WITH NO LOSS OF PRIME OR DELIVERY INTERRUPTION OCCURRING DURING TESTING. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED SUCCESSFULLY. THE COVER WAS REMOVED AND NO MOISTURE INGRESS WAS FOUND. NO POWER CIRCUIT AND FORCE SENSOR CIRCUIT INTERMITTENT CONDITION WAS FOUND. THE COMPLAINT WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013, ALLEGING ELEVATED BLOOD GLUCOSE (BG) >600 MG/DL UPON WAKING IN THE MORNING. THE PATIENT REPORTEDLY CALLED EMS DUE TO ELEVATED BG, SHORTNESS OF BREATH, NAUSEA AND LARGE KETONES. THE PATIENT REPORTED A HISTORY OF A HEART ATTACK AND CARDIAC BYPASS SURGERY IN (B)(6) OF 2012 AND "WAS AFRAID OF WHAT MIGHT HAPPEN." THE PATIENT WAS TAKEN TO THE HOSPITAL AND ADMITTED TO THE ICU FOR FIVE DAYS AND TREATED WITH AN INSULIN DRIP. THE PATIENT DID NOT PROVIDE ANY INFORMATION REGARDING HOSPITAL DISCHARGE; HOWEVER, SHE DID STATE THAT SHE HAS BEEN SEEN BY HER HEALTHCARE PROVIDE SINCE BEING DISCHARGED FROM THE HOSPITAL AND WAS ON A BACKUP PLAN FOR INSULIN DELIVERY. THE PATIENT STATED THAT SHE DID NOT HEAR ANY PUMP ALARMS AND FURTHER STATED THAT SHE IS A VERY SOUND SLEEPER AND DOES NOT NORMALLY HEAR ALARMS WHILE RESTING; HOWEVER, THE PATIENT STATED SHE WAS GETTING 10 LOSS OF PRIME WARNINGS PER DAY. THE PATIENT REPORTED THAT SHE CHANGED THE SITE/SET/CARTRIDGE WITH EACH LOSS OF PRIME ALARM. TROUBLESHOOTING BY CUSTOMER TECHNICAL SUPPORT REVEALED THAT THE PATIENT HAD RE-PRIMED THE PUMP SIX TIMES THE DAY OF THE CALL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED ELEVATED BG AND HOSPITALIZATION WHILE ON INSULIN PUMP THERAPY. THE PUMP CORRECTLY DETECTED THE LOSS OF PRIME ISSUES AND EMITTED LOSS OF PRIME ALARMS TO THE ALERT THE USER; HOWEVER, THE USER CONTINUED TO USE THE PUMP FOR INSULIN DELIVERY DESPITE REPEATED LOSS OF PRIME ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182596 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| L| R