MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. LIBRE APP; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE

Device Problems Application Program Problem (2880); Compatibility Problem (2960); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2022

Event Type  malfunction  

Event Description

Freestyle libre 14 day system.Fine with version 1.No issues as it worked perfectly with the supplied meter.Then version 2 came out and the meter with version 1 would destroy the sensor for version 2 -- you have to use a smart phone which his only uses apple operating version 16 and it won't work.Then abbott it came out with version 3 and he had both apps for version 2 and 3 on his phone and it ruined the version 3 sensor.No reliability.Has to resort to finger sticks.There is no mention of these issues of multi-version products.Abbott just wants him to send the machines/sensors to him for testing but this does not solve his pressing issue of needed a reliable system to track his blood sugar.He has cancer and the paclitaxel has a tendency to raise his blood sugar.His insurance does not account for the ruined sensors and then he is out money and the ability to monitor his blood sugar.This report is for version 3 (the other submitted report for version 2).Fda safety report id (b)(4).

• Brand Name: LIBRE APP
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 15906127
• MDR Text Key: 304867386
• Report Number: MW5113581
• Device Sequence Number: 3
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 11/29/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: POTASSIUM, CLARITIN.; VALSARTAN, VOTRIENT, PACLITAXEL, ZOFRAN, DIPHENHYDRAMINE, TRESIBA, HUMALOG, CRESTOR, NEXIUM, SINGULAIR.
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 166 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White