ONETOUCHPING GLUCOSEMGMTSYSTEM
Report
- Report Number
- 2531779-2016-17859
- Event Type
- Malfunction
- Date Received
- July 28, 2016
- Report Date
- June 30, 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
OF THE 1583 ALLEGATIONS OF A MALFUNCTION, 966 PUMPS WERE RETURNED TO ANIMAS AND INVESTIGATED. OF THE INVESTIGATED PUMPS, 909 WERE FOUND TO BE MALFUNCTIONING DUE TO A DIM AND DISCOLORED DISPLAY. DURING INVESTIGATION FOR UNRELATED ALLEGATIONS, THERE WERE 902 ADDITIONAL INSTANCES OF A DIM AND DISCOLORED DISPLAY SCREEN. THIS REPORT IS PROCESSED UNDER EXEMPTION NUMBER E2015053. THIS MDR REPORT IS PART OF THE 227 PILOT PROGRAM.
FOLLOW UP #3 04/21/2017 DEVICE EVALUATION: IN Q1 2017 THERE WERE 21 ADDITIONAL INSTANCES OF DIM/FADING/COLOR SPECTRUM 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.
FOLLOW-UP #1 DATE OF SUBMISSION 10/25/2016 - DEVICE EVALUATION: IN Q3 2016 72 PUMPS WERE RETURNED AND INVESTIGATED. THERE WERE 67 INSTANCES OF DIM/FADING/COLOR SPECTRUM ISSUES FOUND DURING INVESTIGATION. THIS REPORT IS PROCESSED UNDER EXEMPTION NUMBER E2015053. THIS MDR REPORT IS PART OF THE 227 PILOT PROGRAM.
IN Q4 2016 THERE WERE 40 ADDITIONAL INSTANCES OF DIM/FADING COLOR SPECTRUM 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 #4 07/28/2017 DEVICE EVALUATION: IN Q2 2017, THERE WERE 10 INSTANCES OF DIM AND DISCOLORED DISPLAY FAILURE FOUND DURING INVESTIGATION. THIS REPORT IS PROCESSED UNDER EXEMPTION NUMBER E2015053. THIS MDR REPORT IS PART OF THE 227 PILOT PROGRAM.
FOLLOW-UP #5: DATE OF SUBMISSION 10/30/2017 - DEVICE EVALUATION: IN Q3 2017, THERE WERE 5 INSTANCES OF DIM/FADING/COLOR SPECTRUM FAILURE FOUND DURING INVESTIGATION. THIS REPORT IS PROCESSED UNDER EXEMPTION NUMBER E2015053. THIS MDR REPORT IS PART OF THE 227 PILOT PROGRAM.
FOLLOW UP #7 26-APR-2018 DEVICE EVALUATION: IN Q1 2018, THERE WERE 7 INSTANCES OF DIM/FADING/COLOR SPECTRUM FAILURE FOUND DURING INVESTIGATION. THIS REPORT IS PROCESSED UNDER EXEMPTION NUMBER E2015053. THIS MDR REPORT IS PART OF THE 227 PILOT PROGRAM.
FOLLOW UP #6 30-JAN-2018 DEVICE EVALUATION: IN Q4 2017, THERE WERE 3 INSTANCES OF DIM/FADING/COLOR SPECTRUM 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 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT THE ONE TOUCH PING MODEL PUMP EXPERIENCED A DIM AND FADING DISPLAY SCREEN ISSUE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. THE PATIENTS ASSOCIATED WITH THIS ALLEGATION RANGED FROM 4-92 YEARS OF AGE AND BETWEEN 0 AND 370 POUNDS. OF THE REPORTED PATIENTS, 639 WERE MALE, 802 WERE FEMALE, AND 142 WERE UNKNOWN.
FOLLOW-UP #1: DATE OF SUBMISSION 19-JUL-2018 - DEVICE EVALUATION: IN QUARTER 2 OF 2018, THERE WERE 2 INSTANCES OF DIM/FADING/COLOR SPECTRUM FAILURE FOUND DURING INVESTIGATION. THIS REPORT IS PROCESSED UNDER EXEMPTION NUMBER (B)(4). THIS MDR REPORT IS PART OF THE 227 PILOT PROGRAM.
DEVICE EVALUATION: IN QUARTER 3 OF 2018, THERE WERE 3 INSTANCES OF DIM/FADING/COLOR SPECTRUM FAILURE FOUND DURING INVESTIGATION. THIS REPORT IS PROCESSED UNDER THE VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 484535 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |