BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Q-CLIQ PEN

    MDR report key: 8040554 · Received November 5, 2018

    Report

    Report Number
    3009340644-2018-00002
    Event Type
    Injury
    Date Received
    November 5, 2018
    Date of Event
    August 26, 2018
    Report Date
    November 2, 2018
    Manufacturer
    SHIRE NPS-PHARMACEUTICALS, INC.
    Product Code
    FMF
    UDI-DI
    6887502032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CLOSURE SUMMARY: PATIENT DID NOT RESPOND TO REQUESTS TO RETURN THE DEVICE TO SHIRE FOR EVALUATION, SO A DEVICE DEFECT OR MALFUNCTION COULD NOT BE CONFIRMED OR EXCLUDED. SHIRE RECREATED THE SCENARIO DESCRIBED IN THE COMPLAINT REPORT, IN WHICH THE PATIENT REMOVED A PARTIALLY USED CARTRIDGE FROM ONE PEN AND INSERTED IT INTO ANOTHER PEN. THIS IS CONTRARY TO THE INSTRUCTIONS FOR USE WHICH STATE "DO NOT REMOVE THE MEDICINE CARTRIDGE FROM THE Q-CLIQ PEN UNTIL THE "DISCARD ON" DATE OR THE MEDICINE CARTRIDGE IS EMPTY." THE INVESTIGATION SHOWED NO ENGAGEMENT BETWEEN THE PISTON AND THE CARTRIDGE STOPPER IF THE PEN IS SWITCHED IN THE MIDDLE OF THE CARTRIDGE USE. THIS PROVIDES EVIDENCE THAT THE REPORTED ISSUE WAS THE RESULT OF THE USER NOT FOLLOWING THE INSTRUCTIONS FOR USE. PATIENTS RECEIVE NATPARA EASE OF USE TRAINING FROM A TRAINED NURSE ON DAY 1, 14, 30, AND 90 AND ADDITIONAL TRAINING IS AVAILABLE BY REQUEST. PART OF THAT TRAINING IS INSTRUCTION ON WHAT NOT TO DO AND HOW TO FOLLOW THE IFU. IN ADDITION, THE TRAINING IS DONE WITH A DEMO KIT AND OBSERVED BY THE TRAINED NURSE TO QUALIFY PROFICIENCY. PATIENTS ALSO RECEIVE A STEP BY STEP VISUAL GUIDE IN ADDITION TO THE IFU, AND VIDEO OF THE USE PROCEDURE IS AVAILABLE ONLINE AND CAN BE VIEWED AT ANY TIME. BASED ON THIS PROGRAM, SHIRE CONSIDERS THE TRAINING ADEQUATE AND NO TREND OF SIMILAR USE ERRORS HAS BEEN DETECTED. THE COMPLAINT INVESTIGATION ALSO DETERMINED THAT THE PEN USED WAS EXPIRED. THE PATIENT IS INFORMED TO ONLY USE PRODUCT AND DEVICES WITHIN THEIR EXPIRATION PERIOD AND TO DISCARD ANY PAST EXPIRATION. ALTHOUGH NOT CONSIDERED A CONTRIBUTING FACTOR IN THIS EVENT, SHIRE HAS INITIATED A CAPA (1345716) TO EVALUATE IMPROVEMENTS TO THE CURRENT PROCESS FOR REPLACING PENS.

    Description of Event or Problem · 0

    PATIENT ADMINISTERING NATPARA (PARATHYROID HORMONE) USING THE Q-CLIQ REUSABLE PEN INJECTOR REPORTED "I DROPPED MY PEN LAST SUNDAY NIGHT, THE BOTTOM OF THE PEN BROKE, THE CARTRIDGE REMAINED INTACT. I WAS ONLY A QUARTER THROUGH THE NEW CARTRIDGE SO I SWITCHED IT TO A NEW CLICK PEN THAT ONE I RECEIVED WHEN I BEGAN INJECTIONS. BY WEDNESDAY MORNING I REALIZED THE PEN'S PLUNGER WAS NOT WORKING AND I WAS NOT RECEIVING ANY MEDICATION AND HAD GONE INTO SEVERE TETANY. I ENDED UP N ICU FOR 2 DAYS AND THEN MOVED TO CARDIAC/TELEMETRY FLOOR UNTIL SATURDAY WHEN MY CALCIUM AND IONIZED CALCIUM WERE ABOVE THE NORMAL RANGE". THE PATIENT WAS HOSPITALIZED FOR A TOTAL OF 4 DAYS. PATIENT DID NOT RESPOND TO REQUESTS TO RETURN THE DEVICE TO SHIRE FOR EVALUATION, SO A DEVICE DEFECT OR MALFUNCTION COULD NOT BE CONFIRMED OR EXCLUDED. BASED ON THE LOT NUMBER PROVIDED BY THE PATIENT, THE PEN USED WAS PAST EXPIRATION. THE PATIENT REMOVED A PARTIALLY USED CARTRIDGE FROM ONE PEN (AFTER DROPPING AND BREAKING THE PEN) AND INSERTED IT INTO ANOTHER PEN. THIS IS CONTRARY TO THE INSTRUCTIONS FOR USE WHICH STATE "DO NOT REMOVE THE MEDICINE CARTRIDGE FROM THE Q-CLIQ PEN UNTIL THE "DISCARD ON" DATE OR THE MEDICINE CARTRIDGE IS EMPTY." INVESTIGATION IS STILL ONGOING TO DETERMINE IF THE INCIDENT WAS CAUSED BY A DEVICE DEFECT, MALFUNCTION, AND/OR USER ERROR. SHIRE WILL MAKE EVERY ATTEMPT POSSIBLE TO RETRIEVE THE DEVICE FROM THE PATIENT TO CONDUCT A FULL INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT ADMINISTERING NATPARA (PARATHYROID HORMONE) USING THE Q-CLIQ REUSABLE PEN INJECTOR REPORTED "I DROPPED MY PEN LAST SUNDAY NIGHT, THE BOTTOM OF THE PEN BROKE, THE CARTRIDGE REMAINED INTACT. I WAS ONLY A QUARTER THROUGH THE NEW CARTRIDGE, SO I SWITCHED IT TO A NEW CLICK PEN THAT ONE I RECEIVED WHEN I BEGAN INJECTIONS. BY WEDNESDAY MORNING I REALIZED THE PEN'S PLUNGER WAS NOT WORKING AND I WAS NOT RECEIVING ANY MEDICATION AND HAD GONE INTO SEVERE TETANY. I ENDED UP N ICU FOR 2 DAYS AND THEN MOVED TO CARDIAC/TELEMETRY FLOOR UNTIL SATURDAY WHEN MY CALCIUM AND IONIZED CALCIUM WERE ABOVE THE NORMAL RANGE". THE PATIENT WAS HOSPITALIZED FOR A TOTAL OF 4 DAYS. PATIENT DID NOT RESPOND TO REQUESTS TO RETURN THE DEVICE TO SHIRE FOR EVALUATION, SO A DEVICE DEFECT OR MALFUNCTION COULD NOT BE CONFIRMED OR EXCLUDED. BASED ON THE LOT NUMBER PROVIDED BY THE PATIENT, THE PEN USED WAS PAST EXPIRATION. THE PATIENT REMOVED A PARTIALLY USED CARTRIDGE FROM ONE PEN (AFTER DROPPING AND BREAKING THE PEN) AND INSERTED IT INTO ANOTHER PEN. THIS IS CONTRARY TO THE INSTRUCTIONS FOR USE WHICH STATE "DO NOT REMOVE THE MEDICINE CARTRIDGE FROM THE Q-CLIQ PEN UNTIL THE "DISCARD ON" DATE OR THE MEDICINE CARTRIDGE IS EMPTY." INVESTIGATION IS STILL ONGOING TO DETERMINE IF THE INCIDENT WAS CAUSED BY A DEVICE DEFECT, MALFUNCTION, AND/OR USER ERROR. SHIRE WILL MAKE EVERY ATTEMPT POSSIBLE TO RETRIEVE THE DEVICE FROM THE PATIENT TO CONDUCT A FULL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876811 Q-CLIQ PEN SYRINGE, PISTON FMF SHIRE NPS-PHARMACEUTICALS, INC. Q-CLIQ PEN P279247A 6887502032

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization