FDA.reportPublic FDA data

MAUDE MDR 9908124

MDR report key
9908124
Report number
3013756811-2020-30124
Event key
0
Event type
3
Date of event
2020-03-08
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MICK TRIER
Address
SAN DIEGO CA 92121 US
Phone
858-858-8584
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEMCONTINUOUS GLUCOSE MONITORDEXCOM, INC.QBJ9445-02STS-OR-001R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

THE TANDEM USER GUIDE STATES, ?MAKE SURE A SENSOR GLUCOSE READING SHOWS IN THE UPPER RIGHT PORTION OF THE CGM HOME SCREEN BEFORE CALIBRATING.? NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

D

Patient 1

IT WAS REPORTED THAT THERE WAS AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) READING AND THE BLOOD GLUCOSE (BG) METER READING. REPORTEDLY, THE CGM BG READING WAS 59 MG/DL, AND THE METER BG READING WAS 161 MG/DL. REPORTEDLY, THE CUSTOMER ENTERED CALIBRATION VALUES DURING PERIODS WHEN NO CGM VALUES WERE PRESENT. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT SENSOR WAS SENT TO THE CUSTOMER.