OMNIPOD INSULIN PUMP
Report
- Report Number
- 3004464228-2018-00487
- Event Type
- Malfunction
- Date Received
- January 26, 2018
- Report Date
- October 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
- OTHER
Narratives
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), 142 (CONTAMINATION BY FOREIGN MATERIAL) - 23 (MANUFACTURING DEFICIENCY): 2, 170 (MANUFACTURING PROCESS PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 5, 213 (NO FAILURE DETECTED) - 67 (COULD NOT CONFIRM): 37, 213 (NO FAILURE DETECTED) - 71 (NO FAILURE DETECTED): 14, 706 (ASSEMBLY PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 3, 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 304, 3227 (POWER SOURCE PROBLEM) ¿ 23 (MANUFACTURING DEFICIENCY): 2, 3233 (RESULTS PENDING COMPLETION OF EVALUATION) ¿ 11 (CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS) - 37, TOTAL: 404,3088 (NEEDLE) - 1158 (FAILURE TO DEPLOY) ¿ 1354 (FLUID LEAK), 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 8, TOTAL: 8,3088 (NEEDLE) ¿ 1158 (FAILURE TO DEPLOY) ¿ 1059 (BENT), 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 1, TOTAL: 1,3088 (NEEDLE) - 1158 (FAILURE TO DEPLOY) - 3026 (UNINTENDED MOVEMENT), 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 1, TOTAL: 1,3088 (NEEDLE) - 1158 (FAILURE TO DEPLOY) - 1059 (BENT) ¿ 1354 (FLUID LEAK), 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 1, TOTAL: 1,3088 (NEEDLE) - 1536 (RETRACTION PROBLEM), 170 (MANUFACTURING PROCESS PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 3, 213 (NO FAILURE DETECTED) - 67 (MANUFACTURING DEFICIENCY): 4, 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 15, 3233 (RESULTS PENDING COMPLETION OF EVALUATION) ¿ 11 (CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS) - 2, TOTAL: 24,3088 (NEEDLE) - 2906 (DEPLOYMENT ISSUE), 170 (MANUFACTURING PROCESS PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 2, 213 (NO FAILURE DETECTED) - 67 (COULD NOT CONFIRM): 143, 213 (NO FAILURE DETECTED) - 71 (NO FAILURE DETECTED): 11, 706 (ASSEMBLY PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 2, 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 337, 3233 (RESULTS PENDING COMPLETION OF EVALUATION) ¿ 11 (CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS) - 35, TOTAL: 530,3088 (NEEDLE) - 2906 (DEPLOYMENT ISSUE) - 1059 (BENT), 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 3, 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 67(COULD NOT CONFIRM): 1, 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 71(NO FAILURE DETECTED): 1, TOTAL: 5,3088 (NEEDLE) - 2906 (DEPLOYMENT ISSUE) - 1354 (FLUID LEAK), 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 1, 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 11(CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS): 1, TOTAL: 2,3088 (NEEDLE) ¿ 2906 (DEPLOYMENT ISSUE) ¿ 3026 (UNINTENDED MOVEMENT), 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 9, 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 67(COULD NOT CONFIRM): 5, 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 11(CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS): 1, TOTAL: 15,3088 (NEEDLE) - 2906 (DEPLOYMENT ISSUE) - 1059 (BENT) ¿ 1354 (FLUID LEAK), 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 2, TOTAL: 2,3088 (NEEDLE) ¿ 2906 (DEPLOYMENT ISSUE) ¿ 3026 (UNINTENDED MOVEMENT) ¿ 1354 (FLUID LEAK), 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 5, TOTAL: 5.EXEMPTION NUMBER: 2014031.TOTAL NUMBER OF EVENTS: 930.
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) 142 (CONTAMINATION BY FOREIGN MATERIAL) - 23 (MANUFACTURING DEFICIENCY): 2, 170 (MANUFACTURING PROCESS PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 5, 213 (NO FAILURE DETECTED) - 67(UNABLE TO CONFIRM COMPLAINT): 37, 213 (NO FAILURE DETECTED) - 71(NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION): 14, 706 (ASSEMBLY PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 3, 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 304, 3227 (POWER SOURCE PROBLEM) ¿ 23 (MANUFACTURING DEFICIENCY): 2, 3233 (RESULTS PENDING COMPLETION OF EVALUATION) ¿ 11 (CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS) - 37, TOTAL: 404, 3088 (NEEDLE) - 1158 (FAILURE TO DEPLOY) ¿ 1354 (LEAK), 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 8, TOTAL: 8, 3088 (NEEDLE) ¿ 1158 (FAILURE TO DEPLOY) ¿ 1059 (BENT), 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 1, TOTAL: 1, 3088 (NEEDLE) - 1158 (FAILURE TO DEPLOY) - 3026 (UNINTENDED MOVEMENT), 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 1, TOTAL: 1, 3088 (NEEDLE) - 1158 (FAILURE TO DEPLOY) - 1059 (BENT) ¿ 1354 (LEAK), 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 1, TOTAL: 1, 3088 (NEEDLE) - 1536 (RETRACTION PROBLEM), 170 (MANUFACTURING PROCESS PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 3, 213 (NO FAILURE DETECTED) - 67 (UNABLE TO CONFIRM COMPLAINT): 4, 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 15, 3233 (RESULTS PENDING COMPLETION OF EVALUATION) ¿ 11 (CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS) - 2, TOTAL: 24, 3088 (NEEDLE) - 2906 (DEPLOYMENT ISSUE), 170 (MANUFACTURING PROCESS PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 2, 213 (NO FAILURE DETECTED) - 67 (UNABLE TO CONFIRM COMPLAINT): 143, 213 (NO FAILURE DETECTED) - 71 (NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION): 11, 706 (ASSEMBLY PROBLEM) - 23 (MANUFACTURING DEFICIENCY): 2, 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 337, 3233 (RESULTS PENDING COMPLETION OF EVALUATION) ¿ 11 (CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS) - 35, TOTAL: 530, 3088 (NEEDLE) - 2906 (DEPLOYMENT ISSUE) - 1059 (BENT), 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 3, 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 67(UNABLE TO CONFIRM COMPLAINT): 1, 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 71(NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION): 1, TOTAL: 5, 3088 (NEEDLE) - 2906 (DEPLOYMENT ISSUE) - 1354 (LEAK), 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 1, 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 11(CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS): 1, TOTAL: 2, 3088 (NEEDLE) ¿ 2906 (DEPLOYMENT ISSUE) ¿ 3026 (UNINTENDED MOVEMENT), 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 9, 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 67(UNABLE TO CONFIRM COMPLAINT): 5, 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 11(CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS): 1, TOTAL: 15, 3088 (NEEDLE) - 2906 (DEPLOYMENT ISSUE) - 1059 (BENT) ¿ 1354 (LEAK), 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 2, TOTAL: 2, 3088 (NEEDLE) ¿ 2906 (DEPLOYMENT ISSUE) ¿ 3026 (UNINTENDED MOVEMENT) ¿ 1354 (LEAK), 3221 (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - 92(DEVICE NOT RETURNED): 5, TOTAL: 5, EXEMPTION NUMBER: 2014031 TOTAL NUMBER OF EVENTS: 998.
THIS REPORT SUMMARIZES 1136 REPORTED EVENTS. FOR EACH EVENT, THE POD¿S NEEDLE MECHANISM FAILED TO DEPLOY AS INTENDED, RESULTING IN A NEEDLE MECHANISM FAILURE. OF THE 1136 TOTAL REPORTED EVENTS, 998 ARE FROM QUARTER 4 OF 2017. THE REMAINING 138 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: 130, MALE: 121, UNKNOWN: 2, GRAND TOTAL: 253; 18-34, 131, 80, 1, 212; 35-51, 124, 109, 1 234; 52-68, 111, 66, NA, 177; 69-84, 22, 12, NA, 34; UNKNOWN: 32, 30, 26, 88; GRAND TOTAL: 550, 418, 30, 998.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 66467 | OMNIPOD INSULIN PUMP | PUMP, INFUSION, INSULIN | LZG | INSULET CORPORATION | 14000 | 20385081120002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |