MAUDE Adverse Event Report: ABBOTT / ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14-DAY CGM; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Model Number JNGY296-T3155

Device Problems Break (1069); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 02/02/2021

Event Type  malfunction  

Event Description

I use an abbott freestyle libre 14 day cgm and have been successfully using this product for over a year.The sensor i started on (b)(6) 2021 worked ok for three days then starting (b)(6) 2021 began giving intermittent readings that seemed intermittent and inaccurate.I checked it against a finger stick and found it to be off by 44%.The cgm read 90 and finger stick was 163.A replacement sensor worked ok.However, upon examination when the cgm was removed i have found that the mechanism that attached the sensor probe to the electronics module appears to be breaking.The product is a two part unit which is latched together when applied to the skin.There are three small plastic barbed prongs which appear to latch the probe to the electronics module.These hold the probe conductive contacts against the circuit board pads for enabling the measurements.I found that all three were broken so that the only thing holding the probe to the module was the fact that the adhesive between the module and my skin was captivating the probe.My background is in medical electronics and i took pictures with my microscope to see this.Additionally, i have carefully performed the same examination on a subsequent cgm module and found that the prongs on this one were also all broken.I assume that the purpose of these prongs is to firmly hold the probe to the module so the electrical contact can be established and maintained.The cgm sensor was removed without mechanical stress so as not to cause any damage to the assembly as i used an adhesive solvent (d-limonene / orange peel oil) for easy removal.I thought i would notify you and if i am wrong with my assumptions, you can disregard, but you may want to investigate, especially if the same mechanism is used in a feedback loop with an insulin pump.This could be a patient safety issue.Fda safety report id # (b)(4).

• Brand Name: FREESTYLE LIBRE 14-DAY CGM
• Type of Device: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): ABBOTT / ABBOTT DIABETES CARE INC.
• MDR Report Key: 11602790
• MDR Text Key: 243643038
• Report Number: MW5100485
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• 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: 03/30/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: JNGY296-T3155
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 69