ONETOUCHPING GLUCOSEMGMTSYSTEM
Report
- Report Number
- 2531779-2016-08720
- Event Type
- Malfunction
- Date Received
- April 28, 2016
- Report Date
- March 31, 2016
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- 003
Narratives
FOLLOW-UP #2 DATE OF SUBMISSION 07/27/2016 - DEVICE EVALUATION: IN Q2 2016 18 PUMPS WERE RETURNED AND INVESTIGATED. THERE WERE 12 INSTANCES OF BATTERY COMPARTMENT DAMAGE FOUND DURING INVESTIGATION. THIS REPORT IS PROCESSED UNDER EXEMPTION NUMBER E2015053. THIS MDR REPORT IS PART OF THE 227 PILOT PROGRAM. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.
FOLLOW-UP #4 DATE OF SUBMISSION 10/25/2016 - DEVICE EVALUATION: IN Q3 2016 1 PUMP WAS RETURNED AND INVESTIGATED. THERE WAS 1 INSTANCE OF BATTERY COMPARTMENT DAMAGE FOUND DURING INVESTIGATION. THIS REPORT IS PROCESSED UNDER EXEMPTION NUMBER E2015053. THIS MDR REPORT IS PART OF THE 227 PILOT PROGRAM.
OF THE (B)(4) ALLEGATIONS OF A MALFUNCTION, (B)(4) PUMPS WERE RETURNED TO ANIMAS AND INVESTIGATED. OF THE INVESTIGATED PUMPS, (B)(4) WERE FOUND TO BE MALFUNCTIONING DUE TO DAMAGE TO THE BATTERY COMPARTMENT. DURING INVESTIGATION FOR UNRELATED ALLEGATIONS, THERE WERE (B)(4) ADDITIONAL BATTERY COMPARTMENT FAILURES REVEALED DURING PRODUCT INVESTIGATION ALSO DUE TO DAMAGE TO THE BATTERY COMPARTMENT. THIS REPORT IS PROCESSED UNDER EXEMPTION NUMBER E2015053. THIS MDR REPORT IS PART OF THE 227 PILOT PROGRAM.
FOLLOW UP #1 06/15/2015 OF THE 403 ALLEGATIONS OF A MALFUNCTION, 320 PUMPS WERE RETURNED TO ANIMAS AND INVESTIGATED. OF THE INVESTIGATED PUMPS, 317 WERE FOUND TO BE MALFUNCTIONING DUE TO DAMAGE TO THE BATTERY COMPARTMENT. DURING INVESTIGATION FOR UNRELATED ALLEGATIONS, THERE WERE 320 ADDITIONAL BATTERY COMPARTMENT FAILURES REVEALED DURING PRODUCT INVESTIGATION ALSO DUE TO DAMAGE TO THE BATTERY COMPARTMENT. THIS REPORT IS PROCESSED UNDER EXEMPTION NUMBER E2015053. THIS MDR REPORT IS PART OF THE 227 PILOT PROGRAM.
FOLLOW-UP #5 DATE OF SUBMISSION 01/26/2017 - DEVICE EVALUATION: IN Q4 2016 THERE WERE 3 ADDITIONAL INSTANCES OF BATTERY COMPARTMENT FAILURES FOUND DURING INVESTIGATION OF PUMPS RETURNED UNDER THIS REPORT. THIS REPORT IS PROCESSED UNDER EXEMPTION NUMBER E2015053. THIS MDR REPORT IS PART OF THE 227 PILOT PROGRAM. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.
FOLLOW-UP #6: DATE OF SUBMISSION 10/30/2017 - DEVICE EVALUATION: IN Q3 2017, THERE WERE 2 INSTANCES OF BATTERY COMPARTMENT FAILURE FOUND DURING INVESTIGATION. THIS REPORT IS PROCESSED UNDER EXEMPTION NUMBER E2015053. THIS MDR REPORT IS PART OF THE 227 PILOT PROGRAM.
THIS REPORT SUMMARIZES <NOE> 403</NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT THE ONE TOUCH PING MODEL PUMP EXPERIENCED A DAMAGED BATTERY COMPARTMENT. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. THE PATIENTS ASSOCIATED WITH THIS ALLEGATION RANGED FROM 0-79 YEARS OF AGE AND BETWEEN 24 AND 426 POUNDS. OF THE REPORTED PATIENTS, 185 WERE MALE, 218 WERE FEMALE, AND 0 WERE UNKNOWN.
OF THE 403 ALLEGATIONS OF A MALFUNCTION, 320 PUMPS WERE RETURNED TO ANIMAS AND INVESTIGATED. OF THE INVESTIGATED PUMPS, 317 WERE FOUND TO BE MALFUNCTIONING DUE TO DAMAGE TO THE BATTERY COMPARTMENT. DURING INVESTIGATION FOR UNRELATED ALLEGATIONS, THERE WERE 320 ADDITIONAL BATTERY COMPARTMENT FAILURES REVEALED DURING PRODUCT INVESTIGATION ALSO DUE TO DAMAGE TO THE BATTERY COMPARTMENT.
FOLLOW-UP #9: DATE OF SUBMISSION 10-JUL-2019. DEVICE EVALUATION: IN QUARTER 2 OF 2019, THERE WERE 1 INSTANCES OF BATTERY COMPARTMENT FAILURE FOUND DURING INVESTIGATION. THIS REPORT IS PROCESSED UNDER THE VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM.
DEVICE EVALUATION: IN QUARTER 4 OF 2018, THERE WERE 1 INSTANCES OF BATTERY COMPARTMENT FAILURE FOUND DURING INVESTIGATION. THIS REPORT IS PROCESSED UNDER THE VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM
DEVICE EVALUATION: IN QUARTER 1 OF 2019, THERE WAS 1 INSTANCE OF BATTERY COMPARTMENT FAILURE FOUND DURING INVESTIGATION. THIS REPORT IS PROCESSED UNDER THE VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM.
THIS REPORT SUMMARIZES <NOE> 403</NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT THE ONE TOUCH PING MODEL PUMP EXPERIENCED A DAMAGED BATTERY COMPARTMENT. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. THE PATIENTS ASSOCIATED WITH THIS ALLEGATION RANGED FROM (B)(6) YEARS OF AGE AND BETWEEN (B)(6) POUNDS. OF THE REPORTED PATIENTS, 185 WERE MALE, 218 WERE FEMALE, AND 0 WERE UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272151 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |