BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    OMNIPOD INSULIN PUMP

    MDR report key: 6981369 · Received October 26, 2017

    Report

    Report Number
    3004464228-2017-05863
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Report Date
    July 1, 2017
    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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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): 135 (DEGRADATION PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 1. 142 (CONTAMINATION BY FOREIGN MATERIAL) - 23 (MANUFACTURING DEFICIENCY): 1. 170 (MANUFACTURING PROCESS PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 2. 213 (NO FAILURE DETECTED) - 27 (TRAINING DEFICIENCY): 1. 213 (NO FAILURE DETECTED) - 67 (COULD NOT CONFIRM): 28. 213 (NO FAILURE DETECTED) ¿ 71 (NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION): 40. 706 (ASSEMBLY PROBLEM) ¿ 23 (MANUFACTURING DEFICIENCY): 1. 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 239. 3233 (RESULTS PENDING COMPLETION OF INVESTIGATION) ¿ 11 (CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS): 26. TOTAL: 339.3088 (NEEDLE) - 1158 (FAILURE TO DEPLOY) - 1031 (FAILURE TO ADHERE OR BOND). 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 1. TOTAL: 1 .3088 (NEEDLE) - 1536 (RETRACTION PROBLEM). 213 (NO FAILURE DETECTED) ¿ 67 (COULD NOT CONFIRM): 1. 213 (NO FAILURE DETECTED) ¿ 71 (NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION): 7. 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 15. 3233 (RESULTS PENDING COMPLETION OF INVESTIGATION) ¿ 11 (CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS): 8. TOTAL: 31.3088 (NEEDLE) - 1536 (RETRACTION PROBLEM) - 1031 (FAILURE TO ADHERE OR BOND). 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 1. TOTAL: 1 .3088 (NEEDLE) - 2906 (DEPLOYMENT ISSUE). 170 (MANUFACTURING PROCESS PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 1. 213 (NO FAILURE DETECTED) ¿ 27 (TRAINING DEFICIENCY): 1. 213 (NO FAILURE DETECTED) ¿ 67 (COULD NOT CONFIRM): 38. 213 (NO FAILURE DETECTED) - 71 (NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION): 86. 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 365. 3233 (RESULTS PENDING COMPLETION OF INVESTIGATION) ¿ 11 (CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS): 56. TOTAL: 547.3088 (NEEDLE) - 2906 (DEPLOYMENT ISSUE) - 1059 (BENT). 213 (NO FAILURE DETECTED) - 71 (NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION): 1. 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 2. TOTAL: 3.3088 (NEEDLE) - 2906 (DEPLOYMENT ISSUE) - 1031 (FAILURE TO ADHERE). 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 2. TOTAL: 2.3088 (NEEDLE) - 2906 (DEPLOYMENT ISSUE) - 3026 (UNINTENDED MOVEMENT). 213 (NO FAILURE DETECTED) - 71 (NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION): 2. 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 5. TOTAL: 7.EXEMPTION NUMBER: 2014031.TOTAL NUMBER OF EVENTS: 931. THE FOLLOWING INFORMATION IS SUPPLEMENTAL DATA FOR PREVIOUSLY SUBMITTED ALTERNATIVE SUMMARY REPORTS. THESE DEVICES WERE RECEIVED AND 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). 114 (OPERATIONAL PROBLEM) ¿ 23 (MANUFACTURING DEFICIENCY): 2. 142 (CONTAMINATION BY FOREIGN MATERIAL) - 23 (MANUFACTURING DEFICIENCY): 4. 170 (MANUFACTURING PROCESS PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 5. 213 (NO FAILURE DETECTED) - 67 (COULD NOT CONFIRM): 8. 213 (NO FAILURE DETECTED) - 71 (NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION): 37. 706 (ASSEMBLY PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 3. TOTAL: 59 .3088 (NEEDLE) - 1158 (FAILURE TO DEPLOY) - 1059 (BENT). 213 (NO FAILURE DETECTED) ¿ 71 (NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION): 1. TOTAL: 1 . 3088 (NEEDLE) - 1536 (RETRACTION PROBLEM). 213 (NO FAILURE DETECTED) - 67 (COULD NOT CONFIRM): 1. 213 (NO FAILURE DETECTED) - 71 (NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION): 5. 706 (ASSEMBLY PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 5 . TOTAL: 11.3088 (NEEDLE) - 2906 (DEPLOYMENT ISSUE). 142 (CONTAMINATION BY FOREIGN MATERIAL) - 23 (MANUFACTURING DEFICIENCY): 1. 170 (MANUFACTURING PROCESS PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 2. 213 (NO FAILURE DETECTED) - 67 (COULD NOT CONFIRM): 16. 213 (NO FAILURE DETECTED) - 71 (NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION): 85. 706 (ASSEMBLY PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 5. 3233 (RESULTS PENDING COMPLETION OF INVESTIGATION) ¿ 93 (PREVIOUSLY INVESTIGATED): 1. TOTAL: 110.3088 (NEEDLE) - 2906 (FAILURE TO DEPLOY) - 1059 (BENT). 213 (NO FAILURE DETECTED) ¿ 71 (NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION): 3. TOTAL: 3. TOTAL NUMBER OF EVENTS: 184.

    Additional Manufacturer Narrative · 1

    CORRECTION: REVISED ASR REPORTING AUTHORIZATION NUMBER ON COVERSHEET AS INCORRECT NUMBER USED IN INITIAL SUBMISSION ATTACHMENT. REVISED FROM E20124031 TO E2014031. REVISED FIRST SENTENCE OF 3RD PARAGRAPH FROM "FOR QUARTER 2 OF 2017" TO "FOR QUARTER 3 OF 2017" AS INCORRECT REPORTING QUARTER STATED IN INITIAL 3500A SUBMISSION.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 1115 REPORTED EVENTS. FOR EACH EVENT, THE POD¿S NEEDLE MECHANISM FAILED TO DEPLOY AS INTENDED, RESULTING IN A NEEDLE MECHANISM FAILURE. OF THE 1115 TOTAL REPORTED EVENTS, 931 ARE FROM QUARTER 3 OF 2017. THE REMAINING 184 REPORTS CONTAIN SUPPLEMENTAL AND/OR CORRECTED ALTERNATIVE SUMMARY REPORT (ASR) DATA FROM PRIOR ASR SUBMISSIONS. FOR QUARTER 2 OF 2017, ADOLESCENT FEMALES (AGE 0 ¿ 17 YEARS) REPORTED 143 EVENTS, WHILE MALES IN THIS AGE BRACKET REPORTED 108 EVENTS. FURTHERMORE, ADULT FEMALES (AGE 18+) REPORTED 367 EVENTS, WHILE MALES IN THIS AGE BRACKET REPORTED 239 EVENTS. ADDITIONALLY, 15 PATIENTS FELL INTO THE CATEGORY OF "UNKNOWN" AS PATIENT INFORMATION FOR AGE AND/OR GENDER WERE NOT AVAILABLE. THERE WERE 7 REMAINING PATIENTS (AGE RANGING BETWEEN 0 - 68 YEAR) WHERE AGE WAS KNOWN AND GENDER WAS NOT KNOWN. CONVERSELY, THERE WERE 27 FEMALES WITH AN UNKNOWN AGE AND 25 MALES WITH AN UNKNOWN AGE. PLEASE SEE THE FOLLOWING TABLE WHICH PROVIDES FURTHER DETAIL FOR THE REPORTED SYMPTOM OF NEEDLE MECHANISM FAILURE: AGE GROUP FEMALE MALE UNKNOWN GRAND TOTAL AGE GROUP: 0-17, FEMALE: 143, MALE: 108, UNKNOWN: 2, GRAND TOTAL: 253; 18-34, 127, 75, 1, 203; 35-51, 135, 92, 0, 227; 52-68, 86, 59, 4, 149; 69-85, 19, 13, 0, 32; UNKNOWN: 27, 25, 15, 67; GRAND TOTAL: 537, 372, 22, 931.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 1115 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 1115 TOTAL REPORTED EVENTS, 931 ARE FROM QUARTER 3 OF 2017. THE REMAINING 184 REPORTS CONTAIN SUPPLEMENTAL AND/OR CORRECTED ALTERNATIVE SUMMARY REPORT (ASR) DATA FROM PRIOR ASR SUBMISSIONS. FOR QUARTER 3 OF 2017, ADOLESCENT FEMALES (AGE 0 ¿ 17 YEARS) REPORTED 143 EVENTS, WHILE MALES IN THIS AGE BRACKET REPORTED 108 EVENTS. FURTHERMORE, ADULT FEMALES (AGE 18+) REPORTED 367 EVENTS, WHILE MALES IN THIS AGE BRACKET REPORTED 239 EVENTS. ADDITIONALLY, 15 PATIENTS FELL INTO THE CATEGORY OF "UNKNOWN" AS PATIENT INFORMATION FOR AGE AND/OR GENDER WERE NOT AVAILABLE. THERE WERE 7 REMAINING PATIENTS (AGE RANGING BETWEEN 0 - 68 YEAR) WHERE AGE WAS KNOWN AND GENDER WAS NOT KNOWN. CONVERSELY, THERE WERE 27 FEMALES WITH AN UNKNOWN AGE AND 25 MALES WITH AN UNKNOWN AGE. PLEASE SEE THE FOLLOWING TABLE WHICH PROVIDES FURTHER DETAIL FOR THE REPORTED SYMPTOM OF NEEDLE MECHANISM FAILURE: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758665 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1