BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3172206 · Received June 17, 2013

    Report

    Report Number
    2531779-2013-08274
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INVESTIGATION FOR THE CARTRIDGE SHOULD READ (B)(4) 2013. DATE OF INVESTIGATION FOR THE PUMP SHOULD READ (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    THE DEVICE 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.

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS INVESTIGATED ON 07/17/2013 AND THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/26/2013 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. A REVIEW OF THE PUMP¿S HISTORY SHOWED SEVERAL LOSS OF PRIMES ASSOCIATED WITH ZERO FORCE ON THE REPORTED EVENT DATE. DURING TESTING, THE PUMP POWERED ON NORMALLY. THE PUMP WAS ABLE TO PRIME SUCCESSFULLY. A 24 HOUR DURATION TEST WAS PERFORMED ON THE PUMP WITH NO LOSS OF PRIME OR DELIVERY INTERRUPTION. THE FORCE SENSOR WAS FOUND TO BE IN CALIBRATION. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. THE PUMP WAS OPENED AND NO DAMAGE OR INTERMITTENT CONDITION WAS FOUND INTERNALLY. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DIM AND DISCOLORED DISPLAY SCREEN. A TEST SCREEN WAS INSTALLED AND DISPLAYED NORMALLY. ADDITIONALLY, THE CARTRIDGE WAS RETURNED TO ANIMAS. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST WAS PERFORMED WITH NO FLUID OBSERVED LEAKING OUT AT THE PLUNGER END OF THE CARTRIDGE. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE, CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT HER BLOOD GLUCOSE (BG) WAS GREATER THAN 600MG/DL WITH IRRITABILITY. THE PATIENT STATED THEY TREATED THEMSELVES WITH AN INJECTION AND BG CAME DOWN TO 400MG/DL. THE PATIENT FELT THAT THE PUMP WAS NOT DELIVERING ALL DAY. SHE STATED THAT SHE HAD BEEN BOLUSING, BOLUSES SAY COMPLETED AND NONE HAVE CANCELLED BUT THE PATIENT FELT THAT THERE WERE NO DROPS COMING OUT DURING BOLUS. THE PATIENT REFUSED TO TRY ANOTHER CARTRIDGE BECAUSE SHE HAD GONE THROUGH THREE CARTRIDGES. CUSTOMER SUPPORT (CS) WANTED PATIENT TO BOLUS IN THE AIR BUT PATIENT REFUSED TO GET ANOTHER CARTRIDGE. THERE IS UNKNOWN REASON WHY PATIENT CANNOT SEE DROPS DURING PRIME AS SHE IS USING THE PROPER TECHNIQUE FOR REWIND, LOAD AND PRIME STEPS. IT WAS NOT KNOWN IF THIS IS RELATED TO CARTRIDGES OR THE PUMP. CS ASKED PATIENT TO MANUALLY PRIME TUBING, STATED THAT SHE COULD NOT AND ALSO HAD THE PATIENT MANUALLY PRIME CARTRIDGE AND STATED THAT SHE COULD NOT SEE DROPS. THE PATIENT FELT THERE WAS A PUMP AND CARTRIDGE ISSUE. THIS REPORT IS BEING MADE DUE TO THE ALLEGED HYPERGLYCEMIC EVENT THAT THE PATIENT EXPERIENCED DUE TO ALLEGATION OF A PRIME ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273594 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Life Threatening