FDA Adverse Event Injury Summary report: N

ANIMAS VIBE INSULIN PEDIATRIC PUMP

MDR report key: 5875023 · Received August 9, 2016

Report

Report Number
MW5064040
Event Type
Injury
Date Received
August 9, 2016
Date of Event
August 5, 2016
Report Date
August 9, 2016
Manufacturer
J AND J
Product Code
OYC
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THIS MORNING AT 9:30, I GOT A MESSAGE FROM ANIMAS VIBE PUMP ABOUT NOT DELIVERING PAIN. I CALLED ANIMAS. THEY FIXED THE PROBLEM. AN HOUR LATER, I GOT ANOTHER MESSAGE ABOUT THE LITHIUM BATTERY, PRIMING AND NOT DELIVERING INSULIN. SO I CALLED ANIMAS AGAIN AND OPENED THE BATTERY COMPARTMENT AND IT LOOKS FINE. HOWEVER, WHEN I INTRODUCED A Q-TIP IT WAS WET. WE DID NOT GO TO THE SWIMMING POOL. IT JUST FAILED AGAIN. TWO CONSECUTIVE PUMPS HAD FAILED IN LESS THAN A WEEK. BESIDES THAT THIS IS THE 4TH PUMP REPLACEMENT. I JUST WANT TO INFORM THAT ANIMAS VIBE BRAND NEW PEDIATRIC SN (B)(4) PUMP FAILED AGAIN FOR THE 4TH CONSECUTIVE TIME. WE HAVE 2 FAILURES IN LESS THAN ONE WEEK AND 4 IN LESS THAN A YEAR. THE EXPERIENCE WITH THIS J AND J COMPANY IS FRUSTRATING. IT LOOKS LIKE THAT INSIDE J AND J DIFFERENT DEPARTMENTS DO NOT COMMUNICATE TO EACH OTHER. I HAD PROBLEMS WITH DELIVERIES (WAITING FOR MORE THAN 3 DAYS TO HAVE A MEDICAL DEVICE AT HOME), WRONG AND INCOMPLETE DELIVERIES ((B)(6)), INFUSION SETS (INSET MANUFACTURED IN (B)(4) MANY TIMES FAILED APART AT THE TIME OF THE INSERTION), SOFTWARE DOWNLOAD THROUGH DIASEND (IT IS NOT UP TODAY AND NOT ALWAYS IS IT COMPATIBLE WITH (B)(6) PRODUCTS), CUSTOMER SERVICE (THIS DEPARTMENT DOES NOT COMMUNICATE PROPERLY TO CUSTOMERS ABOUT REPLACEMENT OF CAP BATTERY COMPARTMENT AND LINKING TO ANOTHER PRODUCT LIKE DEXCOM), INVOICE DEPARTMENT LOST PAPERS OF APPROVAL SINCE (B)(6) 2015. NOW ANIMAS WANTS ME TO PAY TWICE FOR A MONTH THAT DOES NOT WORK (I SENT PROOF OF PAYMENT AT LEAST 4 TIMES BY EMAIL AND FAX), AND BESIDES THAT ANIMAS BRAND NEW PEDIATRIC MODEL IS OBSOLETE SINCE IT DOES NOT WORK WITH DEXCOM G5, AND EVEN THOUGH IT USED TO WORK WITH DEXCOM G4 BUT IT WAS NOT COMMUNICATING TO EACH OTHER BECAUSE INFORMATION HAS TO BE INPUTTED TWICE IN BOTH ELECTRONIC DEVICES. RESEARCH AND DEVELOPMENT DEPARTMENT NEVER TOLD US WHAT HAPPENED OR WHAT WAS WRONG WITH PREVIOUS PUMPS. I WANT TO REACH OUT TO YOU, SO YOU CAN ALSO INVESTIGATE AND IF NECESSARY INFORM MORE FAMILIES ABOUT THE INCONVENIENCES WITH THIS PUMP - COMPANY TO PROBABLY HAVE A RECALL OF THIS PUMP. SINCE WE PARENTS RELY ON THIS MEDICAL DEVICE TO HAVE A BETTER CONTROL OF BLOOD GLUCOSE LEVELS. MY SON IS ONLY (B)(6) AND WAS DIAGNOSED AT AGE (B)(6) WITH TYPE 1 DIABETES. WE FOLLOW ENDOCRINOLOGIST RECOMMENDATIONS ABOUT THE USE OF THIS PUMP AS WELL AS ANIMAS TRAININGS. THE IDEA OF TRANSITIONING MY SON FROM SYRINGES TO A PUMP WAS TO IMPROVE HIS A1C. HE HAS A LINK TO HIS DEXCOM SENSOR AND THEREFORE HAS A BETTER CONTROL OF HIS BLOOD SUGAR LEVELS. ON THE OTHER HAND HIS A1C HAS INCREASED SINCE THE USE OF HIS PUMP FROM 7.5 TO 9.5. PUMP IS NOT LINKED TO DEXCOM G5 SENSOR, AND HIS BG LEVELS ARE HIGHER. THEREFORE NONE OF THEM ARE WORKING. PROBABLY WE CAN CONSIDER THE USE OF ANOTHER PUMP THAT FITS HIS AGE, LIBRE GLUCOMETER FROM GLAXO NEEDS TO BE RELEASED AND APPROVED BY FDA, STEM CELLS, OR SOMETHING ELSE. MY SON IS SCARED OF INJECTIONS AND PROBABLY THIS WAS ONE OF THE REASONS TO TRANSITION TO A PUMP. TO AVOID SYRINGES AND FLEXIBILITY TO ADMINISTER INSULIN FOR INTAKES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
514534 ANIMAS VIBE INSULIN PEDIATRIC PUMP ANIMAS VIBE INSULIN PEDIATRIC PUMP OYC J AND J
514535 ANIMAS VIBE INSULIN PEDIATRIC PUMP ANIMAS VIBE INSULIN PEDIATRIC PUMP OYC J AND J
514536 ANIMAS VIBE INSULIN PEDIATRIC PUMP ANIMAS VIBE INSULIN PEDIATRIC PUMP OYC J AND J
514537 ANIMAS VIBE INSULIN PEDIATRIC PUMP ANIMAS VIBE INSULIN PEDIATRIC PUMP OYC J AND J

Patients

Seq Age Sex Outcome Treatment
1 5 YR Other| R