MAUDE MDR 8274119

MDR report key
8274119
Report number
MW5083344
Event key
0
Event type
3
Date of event
2019-01-08
Date received
2019-01-23
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
0ABBOTT FREESTYLE LIBRE 14 CONTINUOUS GLUCOSE MONITORSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTERABBOTT DIABETES CARE INC.NBWFREESTYLE LIBRE 14 READER & SENSI Y
1ABBOTT FREESTYLE LIBRE 14 CONTINUOUS GLUCOSE MONITORCONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWAREABBOTT LABORATORIESPHVFREESTYLE LIBRE 14 READER & SENSI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-2301. O

Event Narratives#

D

Patient 1

FAILURE OF DATA RECORDING CORRELATED WITH MANUAL SENSOR READS. AT 04:10 HOURS A MANUAL SENSOR READ WAS PERFORMED ON (B)(6) 2019. CORRELATED WITH THIS MANUAL SENSOR READ, THE SENSOR FAILED TO MAKE ITS GLUCOSE MEASUREMENTS AT 15 MINS INTERVALS LEAVING A DATA GAP FOR THE NEXT 3 HOURS AND 6 MINS. THIS IS A RELIABILITY PROBLEM WITH THE SENSOR AND CREATES ISSUES OF CONFIDENCE IN THIS DEVICE. MULTIPLE DATA GAP PROBLEMS OCCUR DURING THE 14 DAY USE CYCLE FOR A SENSOR. OTHER REPORTS FOR PREVIOUS SENSOR FAILURES HAVE BEEN FILED. BASED ON THE INFO I HAVE GIVEN IN THIS REPORT, AND MY 12 PREVIOUS REPORTS I HAVE DETERMINED THAT THIS DEVICE IS UNRELIABLE AND I HAVE CEASED USING IT. I HAVE HAD LENGTHY TELEPHONE CONVERSATIONS WITH ABBOTT PERSONNEL. THEY FINALLY SAID THE ISSUE WOULD BE ESCALATED TO THE NEXT LEVEL AND THAT I WOULD BE CONTACTED BY A PERSON AT THAT LEVEL WITHIN ONE OR TWO DAYS FROM (B)(6) 2019 WHEN THAT CONVERSATION TOOK PLACE. I HAVE NOT BEEN CONTACTED BY ANYONE AND BELIEVE ABBOTT IS IGNORING ME AND HOPING I WILL GIVE UP AND GO AWAY. I HAVE INFORMED MY PHYSICIAN ABOUT THE RELIABILITY OF THIS DEVICE AND THAT I HAVE STOPPED USING IT AND RESUMED WITH FINGER STICKS.