BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOPEN 4

    MDR report key: 2253185 · Received September 1, 2011

    Report

    Report Number
    9681821-2011-00030
    Event Type
    Other
    Date Received
    September 1, 2011
    Report Date
    August 3, 2011
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY INVESTIGATION AND RESULTS: TECHNICAL, VISUAL, AND FUNCTIONAL EXAMINATIONS WERE PERFORMED. THE DEVICE WAS TESTED WITH A RANDOM PENFILL CARTRIDGE AND A NEW NOVOFINE NEEDLE MOUNTED. THE DEVICE WAS DISASSEMBLED TO INVESTIGATE INTERNAL PARTS. THE PUSH-BUTTON MAY BLOCK AND THE PISTON ROD MOVES BACKWARDS DURING DOSAGE SELECTION. AN INTERNAL PART IS BROKEN, BUT DUE TO THE PEN CONSTRUCTION THE DOSE ACCURACY IS NOT AFFECTED. CONCLUSION: THE FAULT IS DUE TO INCORRECT HANDLING DURING USE OF DEVICE.

    Description of Event or Problem · 1

    PEN IS NOT DIALING UP AS USUAL [DEVICE MALFUNCTION]. CASE DESCRIPTION: THE INCIDENT DOES NOT REPRESENT A SERIOUS PUBLIC HEALTH THREAT. CLASS IIB. SPONTANEOUS REPORT RECEIVED FROM (B)(4) AND REPORTED BY A CONSUMER AS "PEN IS NOT DIALING UP AS USUAL." IT CONCERNS A PATIENT (GENDER AND AGE UNKNOWN) TREATED WITH NOVOPEN 4 (INSULIN DELIVERY DEVICE) (DRUG FIRST DOSE UNKNOWN, DRUG STOP DATE UNKNOWN) FOR "DEVICE THERAPY." UPON ANALYSIS OF THE RETURNED PRODUCT THE PUSH-BUTTON MAY BLOCK AND THE PISTON ROD MOVES BACKWARDS DURING DOSAGE SELECTION. AN INTERNAL PART IS BROKEN, BUT DUE TO THE PEN CONSTRUCTION THE DOSE ACCURACY IS NOT AFFECTED. THIS CASE WAS RECLASSIFIED TO AN INCIDENT DUE TO THIS FAULT. ANALYSIS RESULT: PRODUCT NAME: NOVOPEN 4. BATCH: (B)(4). INVESTIGATION AND RESULTS: TECHNICAL, VISUAL, AND FUNCTIONAL EXAMINATIONS WERE PERFORMED. THE DEVICE WAS TESTED WITH A RANDOM PENFILL CARTRIDGE AND A NEW NOVOFINE NEEDLE MOUNTED. THE DEVICE WAS DISASSEMBLED TO INVESTIGATE INTERNAL PARTS. THE PUSH-BUTTON MAY BLOCK AND THE PISTON ROD MOVES BACKWARDS DURING DOSAGE SELECTION. AN INTERNAL PART IS BROKEN, BUT DUE TO THE PEN CONSTRUCTION THE DOSE ACCURACY IS NOT AFFECTED. CONCLUSION: THE FAULT IS DUE TO INCORRECT HANDLING DURING USE OF DEVICE. THE OBSERVED PROBLEM ON THE PUSH-BUTTON IS DUE TO INCORRECT HANDLING DURING USE. COMPANY COMMENT: UPON ANALYSIS A FAULT WHICH COULD LEAD TO AN INCIDENT WAS IDENTIFIED. THE PUSH-BUTTON WAS BLOCKED AND THE PISTON ROD MOVES BACKWARDS DURING DOSAGE SELECTION. AN INTERNAL PART IN THE PEN IS BROKEN, BUT DUE TO THE PEN CONSTRUCTION THE DOSE ACCURACY IS NOT AFFECTED IF THE PEN IS USED ACCORDING TO THE INSTRUCTION. HOWEVER, IF THE CUSTOMER AFTER CHANGING THE PENFILL IS SETTING THE DOSE BEFORE RETURNING THE PISTON ROD AND NEGLECTING TO PRIME THE PEN, THE PATIENT COULD RECEIVE A TOO HIGH DOSE AND EXPERIENCE A HYPOGLYCEMIC EVENT. THE FAULT SHOULD INITIALLY BE OBVIOUS TO THE PATIENT, BECAUSE OF THE CHANGE IN INJECTION FORCE AND THE OVERALL RISK OF AN ADVERSE EVENT IS CONSIDERED MINIMAL. FINAL COMMENT FROM THE MANUFACTURER: 08-08-2011: DURING INVESTIGATION OF THE DEVICE A FAULT WHICH COULD LEAD TO AN INCIDENT WAS IDENTIFIED. TWO CASES HAVE BEEN REPORTED WITH ADVERSE EVENTS, IN CONNECTION TO A FAULT SIMILAR TO THAT IN CASE (B)(4). IT WAS ESTIMATED THAT THE FAULT FOUND DID NOT HAVE CAUSAL RELATIONSHIP WITH ADVERSE EVENTS REPORTED IN THE CASES. THE REPORTING RATE FOR THE REPORTS, WHERE A SIMILAR FAULT AS THAT SEEN IN (B)(4) HAS BEEN FOUND, IS LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOPEN 4 INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS NA YUG0682

    Patients

    Seq Age Sex Outcome Treatment
    1 Other