BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    OMNIPOD INSULIN PUMP

    MDR report key: 8021155 · Received October 30, 2018

    Report

    Report Number
    3004464228-2018-07397
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Report Date
    July 1, 2018
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120002
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE, EVALUATION CODES WERE UPDATED ON 5JULY2018; SPECIFICALLY, ¿DEVICE CODE 1059 (BENT)¿ WHICH IS NOW INACTIVATED. ¿DEVICE CODE 2981 (MATERIAL TWISTED)¿ HAS BEEN USED AS A REPLACEMENT FOR THE INACTIVATED ¿DEVICE CODE 1059 (BENT)¿ AND REFLECTED AS PART OF THIS Q3 2018 ALTERNATIVE SUMMARY REPORT SUBMISSION. NOT ALL DEVICES WERE RECEIVED FOR EVALUATION. IN THESE CASES, WE WERE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE THROUGH FAILURE ANALYSIS INVESTIGATION.ALL DEVICES RECEIVED UNDERWENT FAILURE ANALYSIS INVESTIGATION. THE RESULTS OF THESE INVESTIGATIONS ARE REPRESENTED, BELOW, ACCORDING TO REPORTED DEVICE, RESULTS, AND CONCLUSIONS CODE COMBINATIONS AND FREQUENCY OF EACH:3088 (NEEDLE) - 1158 (FAILURE TO DEPLOY) 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 11 (CONCLUSION NOT YET AVAILABLE): 492 3233 (RESULTS PENDING COMPLETION OF EVALUATION) - 11 (CONCLUSION NOT YET AVAILABLE): 3 121 (SHORT CIRCUIT) - 12 (DESIGN DEFICIENCY): 11 3242 (STIFFNESS PROBLEM) - 12 (DESIGN DEFICIENCY): 4 102 (INCOMPATIBLE COMPONENT/ ACCESSORY) - 23 (MANUFACTURING DEFICIENCY): 2 114 (OPERATIONAL PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 7 170 (MANUFACTURING PROCESS PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 1 706 (ASSEMBLY PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 2 135 (DEGRADATION PROBLEM) - 67 (NO PROBLEM DETECTED): 5 135 (DEGRADATION PROBLEM) - 3227 (POWER SOURCE PROBLEM) - 67 (NO PROBLEM DETECTED): 1 213 (NO FAILURE DETECTED) - 67 (NO PROBLEM DETECTED): 58 135 (DEGRADATION PROBLEM) - 4307 (CAUSE TRACED TO COMPONENT FAILURE): 1 3227 (POWER SOURCE PROBLEM) - 4307 (CAUSE TRACED TO COMPONENT FAILURE): 1 TOTAL: 588 3088 (NEEDLE) - 1158 (FAILURE TO DEPLOY) - 2981 (MATERIAL TWISTED) 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 11 (CONCLUSION NOT YET AVAILABLE): 7 135 (DEGRADATION PROBLEM) - 3227 (POWER SOURCE PROBLEM) - 67 (NO PROBLEM DETECTED): 1 TOTAL: 83088 (NEEDLE) - 1158 (FAILURE TO DEPLOY) - 1354 (LEAK / SPLASH) 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 11 (CONCLUSION NOT YET AVAILABLE): 2 TOTAL: 2 3088 (NEEDLE) - 1536 (RETRACTION PROBLEM) 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 11 (CONCLUSION NOT YET AVAILABLE): 53 170 (MANUFACTURING PROCESS PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 6 213 (NO FAILURE DETECTED) - 67 (NO PROBLEM DETECTED): 3 TOTAL: 623088 (NEEDLE) - 2906 (ACTIVATION, POSITIONING OR SEPARATION PROBLEM) 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 11 (CONCLUSION NOT YET AVAILABLE): 514 3233 (RESULTS PENDING COMPLETION OF EVALUATION) - 11 (CONCLUSION NOT YET AVAILABLE): 3 121 (SHORT CIRCUIT) - 12 (DESIGN DEFICIENCY): 3 114 (OPERATIONAL PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 1 706 (ASSEMBLY PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 1 135 (DEGRADATION PROBLEM) - 67 (NO PROBLEM DETECTED): 2 213 (NO FAILURE DETECTED) - 67 (NO PROBLEM DETECTED): 94 TOTAL: 6183088 (NEEDLE) - 2906 (ACTIVATION, POSITIONING OR SEPARATION PROBLEM) - 2981 (MATERIAL TWISTED) 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 11 (CONCLUSION NOT YET AVAILABLE): 5 213 (NO FAILURE DETECTED) - 67 (NO PROBLEM DETECTED): 2 TOTAL: 7EXEMPTION NUMBER: 2014031TOTAL NUMBER OF EVENTS: 1285

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE>1607</NOE> REPORTED EVENTS. FOR EACH EVENT, THE POD¿S NEEDLE MECHANISM FAILED TO DEPLOY AS INTENDED, RESULTING IN A NEEDLE MECHANISM FAILURE. REFER TO (ADDITIONAL MANUFACTURER NARRATIVE) FOR DETAILED BREAKDOWN OF SPECIFIC DEVICE CODES COMPARED TO INVESTIGATION FINDINGS. OF THE 1607 TOTAL REPORTED EVENTS, 1285 ARE FROM QUARTER 3 OF 2018. THE REMAINING 322 REPORTS CONTAIN SUPPLEMENTAL AND/OR CORRECTED ALTERNATIVE SUMMARY REPORT (ASR) DATA FROM PRIOR ASR SUBMISSIONS. PLEASE SEE THE FOLLOWING TABLE WHICH PROVIDES FURTHER DETAIL FOR THE REPORTED SYMPTOM OF NEEDLE MECHANISM FAILURE: AGE GROUP: 0-17, FEMALE: 143, MALE: 157, UNKNOWN: 17, GRAND TOTAL: 317; 18-34, 132, 115, 5, 252; 35-51, 145, 133, 8, 286; 52-68, 125, 97, 6, 228; 69-89, 29, 36, 1, 66; UNKNOWN: 39, 44, 53, 136; GRAND TOTAL 613, 582, 90, 1285.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857994 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1