BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3038958 · Received April 5, 2013

    Report

    Report Number
    2531779-2013-03737
    Event Type
    Injury
    Date Received
    April 5, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(4) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION OF THE PUMP¿S HISTORY SHOWED ONE LOSS OF PRIME WARNING ASSOCIATED WITH A NON ZERO LOW FORCE ON (B)(4) 2013. DURING INVESTIGATION, A 1 UNIT PER HOUR BASAL PROGRAM WAS EXECUTED FOR 24 HOURS WITH NO LOSS OF PRIME OR ANY OTHER PRIME RELATED WARNINGS DUPLICATED. A FORCE SENSOR CALIBRATION TEST SHOWED THAT THE PUMP WAS NOT DETECTING THE CORRECT FORCE AT 5 LBS. THE FORCE SENSOR RESISTANCE WAS FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP WAS OPEN AND NO DEFECT WAS FOUND TO THE FORCE SENSOR PINS OR INTERNAL CIRCUIT BOARD. THE COMPLAINT WAS OBSERVED IN THE PUMP¿S HISTORY BUT COULD NOT BE DUPLICATED. 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 BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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) 2013, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: ONE WEEK AGO THE PUMP BEGAN EMITTING LOSS OF PRIME WARNINGS: SHE DISCONNECTED AND PRIMED TUBING. THESE ALARMS OCCURED 6 TIMES IN A ROW. PATIENT WOULD PRIME TUBING AND THEN WITHIN 1 MINUTE SHE WOULD GET ANOTHER WARNING. NO INSULIN WAS BEING PUSHED OUT DURING LOAD STEP. PATIENT DISCONTINUED PUMP AT THAT TIME AND WENT ONTO SYRINGES. HER BLOOD GLUCOSE (BG) WAS WITHIN NORMAL LIMITS AT THAT TIME. IN THE WEEK THE PATIENT HAS BEEN OFF THE PUMP, HER BG HAS BEEN IN 300-500MG/DL RANGE, NEGATIVE FOR KETONES. SHE HAS EXPERIENCED SEVERE NAUSEA, MODERATE CHEST HEAVINESS, VERY TIRED AND DIZZY. SHE TREATS WITH SYRINGE AND CAN GET BG DOWN TO MID 100MG/DL RANGE, HOWEVER BY THE NEXT MORNING HER BG IS BACK UP AGAIN. THE PATIENT REPORTS THAT SUPPLIES STORED AT ROOM TEMPERATURE, SHE CHANGES CARTRIDGE EVERY 1-2 DAYS AND HAD JUST CHANGED CARTRIDGE THE MORNING OF THE DAY THE LOSS OF PRIME ALARMS BEGAN. PATIENT DID NOT CHANGE CARTRIDGE AGAIN THE DAY BEFORE DISCONTINUING PUMP. STATES SHE IS NOT AWARE OF ANY LOOSE CONNECTIONS, DENIES TRAUMA TO PUMP OR EXPOSURE TO EXTREME TEMPERATURE CHANGE. SHE REPORTS NO OTHER ALARMS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT A PATIENT EXPERIENCED HYPERGLYCEMIA AFTER DISCONTINUING THE PUMP DUE TO A PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140736 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Life Threatening