FDA Adverse Event Other Summary report: N

ABBOTT FREESTYLE NAVIGATOR

MDR report key: 1648196 · Received March 26, 2010

Report

Report Number
MW5015336
Event Type
Other
Date Received
March 26, 2010
Report Date
March 26, 2010
Manufacturer
ABBOTT
Product Code
NBW
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MD, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAVE HAD SEVERAL LOW BLOOD GLUCOSE PROBLEMS WHILE I WAS USING THE ABBOTT NAVIGATOR. I DO NOT REMEMBER THE EXACT DATES. I WAS UNABLE TO INSTALL THEIR SOFTWARE THAT IS SUPPOSED TO TRANSFER DATA TO MY COMPUTER AND NOW THAT THE RECEIVER IS NOT WORKING, THE DATA IS LOST. I USED THE MEDTRONIC PUMP AND CGM FOR TWO AND A HALF YEARS. I DECIDED TO SWITCH TO THE NAVIGATOR AND STARTED ON IT IN (B) (6). FOR THE FIRST WEEK OR SO, IT SEEMED TO WORK FAIRLY WELL EXCEPT THAT I HAD TROUBLE CALIBRATING IT. LATER I HAD SEVERAL OTHER PROBLEMS. THE TRANSMITTER FELL OFF TWICE EVEN THOUGH IT HAD SEEMED SECURELY ATTACHED. ONCE IT FELL OFF INTO DAMP CHICKEN DUNG SO I NEEDED TO GET A NEW ONE. THE OTHER TIME IT JUST FELL OFF IN MY HOUSE, SO I WAS ABLE TO REATTACH IT. THE COMPANY ADMITS THAT THE ADHESIVE BANDAGE THAT THEY SUPPLY TO USE OVER THE TRANSMITTER DOES NOT WORK VERY WELL. IF YOU COMPARE THE TRANSMITTER AND THE SIZE AND SHAPE OF THE BANDAGE THEY SUPPLY, IT WILL ONLY TAKE YOU 5 MINUTE TO SEE WHY IT DOES NOT WORK. I DID NOT SEEM TO GET CONSISTENTLY ACCURATE GLUCOSE MEASUREMENTS WITH THE DEVICE. IT ALSO DID NOT LIKE TO TAKE MY CALIBRATIONS. AT TIMES, THE CALIBRATIONS QUITE DIFFERENT FROM MY FINGER STICKS. CUSTOMER SERVICES RECOMMENDS A LIMITED SCHEDULE OF RECALIBRATIONS EVEN IF THE CGM READINGS ARE LESS THAN ACCURATE. I HAD A COUPLE OF LOW GLUCOSE READINGS RELATED TO THE CGM AND MY HUSBAND, A PHYSICIAN DID NOT WANT ME TO CONTINUE TO USE THE NAVIGATOR. BECAUSE MY NAVIGATOR READINGS WERE PROBLEMATIC, I REATTACHED MY OLD MEDTRONIC CGM AND RAN THEM SIMULTANEOUSLY. I ACTUALLY GOT BETTER READINGS WITH THE OLD -OUT OF WARRANTY- MEDTRONIC CGM. -I ALSO DID A LOT OF EXTRA FINGER STICKS.- SEVERAL WEEKS AGO, WHEN I WAS TRUDGING THROUGH OUR DEEP (B) (6) SNOW TO FEED MY CHICKENS, MY NAVIGATOR RECEIVER FELL OUT OF MY COAT POCKET INTO THE SNOW. THE UNIT IS VERY SENSITIVE TO MOISTURE SO THAT MADE THE UNIT STOP WORKING. I HAD STOPPED USING THE SUPPLIED BELT CLIP BECAUSE THE RECEIVER UNIT KEPT FALLING OFF THEIR BELT CLIP. I CALLED ABBOTT AND THEY SAID THAT THEY WOULD REPLACE THE RECEIVER. AFTER I HAD NOT RECEIVED IT, I CALLED BACK AND FOUND THAT THEY ARE NOT SENDING OUT ANY NEW UNITS. THEY WILL NOT EVEN TELL THEIR CUSTOMER SERVICES REP WHY THE UNITS ARE ALL ON HOLD. THEY WILL NOT GIVE US ANY INDICATION ABOUT WHEN ANY NEW UNITS WILL BE SHIPPED. GIVEN MY PROBLEMS WITH INACCURATE READINGS, I WONDER IF THERE IS SOMETHING WRONG WITH THE MANUFACTURE OF THE RECEIVERS. FREQUENCY: CHANGE Q 5 DAYS. ROUTE: SQ. DATES OF USE: (B) (6) 2010 - (B) (6) 2010. DIAGNOSIS: DIABETES. EVENT ABATED AFTER USE STOPPED: YES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ABBOTT FREESTYLE NAVIGATOR CGM CONTINUOUS GLUCOSE MONITOR NBW ABBOTT NAV00016829

Patients

Seq Age Sex Outcome Treatment
1 53 YR Other