MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE2 SENOR AND APPLICATOR; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE

Model Number 71992

Device Problems Device Difficult to Setup or Prepare (1487); Retraction Problem (1536); Detachment of Device or Device Component (2907)

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

Event Date 01/31/2023

Event Type  malfunction  

Event Description

I am going to report 2 separate incidents with the same product, that had the same potential dangerous occurrences.They occurred on (b)(6) 2023 and (b)(6) 2023.The product is the freestyle libre 2 sensor for continuous glucose monitoring.Not withstanding the fact that both times i applied the sensors, i received an error message to check skin placement or remove sensor, which meant an expensive product did not work, on the two occasions, the metal guide on the applicator that guides the sensor into the sq tissue, detached from the applicator and was left 3/4 through the sensor, and into my skin; when if working properly, the metal guide would have retracted back into the applicator.Had i not noticed the needle detached and remained in my skin on 2 occasions, and just covered the sensor which i sometimes do, i would have had a retained inappropriate foreign body in my skin and subcutaneous tissue that could have led to several untowards complications; which could have led to mild to serious complications.I did call abbott about this and reported the problem on both occasions, something i should not have had to do if it was a functioning product.On (b)(6) 2023, i did asked the abbott representative ben if complaints such as mine were common to him, and he replied yes.So the potential dangers are just not limited to me.How widespread the problem is, i do not know, but my guess is countless others also could be in danger.Unfortunately i had to return the sensor to abbott in order to obtain a replacement.

• Brand Name: FREESTYLE LIBRE2 SENOR AND APPLICATOR
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 16295544
• MDR Text Key: 308915038
• Report Number: MW5114672
• Device Sequence Number: 1
• 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: Patient
• Type of Report: Initial
• Report Date: 02/01/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Model Number: 71992
• Device Catalogue Number: 71992
• Device Lot Number: KTP005312
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: FOR THE PURPOSES OF THIS PRODUCT, DIABETES MELLITUS AND USING CONTINUOUS GLUCOSE MONITOR.
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White