FDA.reportPublic FDA data

MAUDE MDR 25341018

MDR report key
25341018
Report number
2954323-2026-101935
Event key
0
Event type
3
Date of event
2026-04-29
Date received
2026-05-31
Adverse event
1
Product problem
0
Patients in event
0
Reporter occupation
3
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Contact
PATRICIA REIS CASTRO
Address
1360 SOUTH LOOP ROAD ALAMEDA CA 94502 US
Phone
415-415-4157
Report source
M

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
193345FREESTYLE LIBRE 2 PLUSFLASH GLUCOSE MONITORING SYSTEMABBOTT DIABETES CARE INCQBJ78747-01NN
288056FREESTYLE LIBRE 2 PLUSFLASH GLUCOSE MONITORING SYSTEMABBOTT DIABETES CARE INCQBJ78747-01NN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12026-05-310O

Event Narratives#

N

Patient 0

THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION AND THE CUSTOMER AGREED TO RETURN THE DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION ACTIVITIES OR IF ADDITIONAL INFORMATION IS OBTAINED. THE DATE OF EVENT IS UNKNOWN. THE DATE ENTERED IN SECTION B3 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

D

Patient 0

A "REPLACE SENSOR" ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE AND THE CUSTOMER WAS UNABLE TO OBTAIN GLUCOSE READINGS. AS A RESULT, THE CUSTOMER REPORTED THEY SELF-TREATMENT OF 5 GLUCOSE TABLETS, DEXTROSE, AND JELLY BABIES. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.