MAUDE Adverse Event Report: ABBOTT DIABETES CARE, INC. FREE STYLE LIBRE 14 DAY; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED

Lot Number 6155291

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Protective Measures Problem (3015)

Patient Problem Hyperglycemia (1905)

Event Date 04/17/2021

Event Type  malfunction  

Event Description

This is a complaint about the abbot free style glucose sensor, specifically the free style libre 14 day sensor.A sensor was being used by me, starting operation about ten days ago, and so was still active, as it lasts for 14 days.The system is made of a sensor, which is placed or inserted into my arm, and a reader which a wireless device to read my sugar.On (b)(6), the system was indicating my sugar was very low (it just read lo for low) and so i took some glucose.After 30 minutes, the device still read lo, and after 60 minutes it still showed the same.At this time, i used my other sugar meter, which i know to be very reliable, and this gave a different number (125mg/dl), which is normal.The device which showed 125mg/dl is a one touch device where i have confirmed its accuracy by comparing its data with data taken by the hospital i now use (b)(6) and i have found that reader to give glucose levels extremely close to the hospital results.As a result, i removed the sensor, and replaced it with another.Then, this morning (b)(6), the new sensor again gave a reading of 49mg/dl, which is very low.When my sugar was tested with the other meter (a one touch device) this showed my sugar to be 122 one time and 124mg/dl, which is quite normal.After, around noon today, a second test was done, and the free style device gave me a reading of 114mg/dl while the one touch as a result, i wish to complain that free style appears to selling devices which give a faulty sugar level.A photo is enclosed, please note that the meter on the left (the one touch device) is not set to daylight saving time, so it shows the time one hour earlier than the free style.The photo shows the erroneous numbers on the free style device for (b)(6).Photos are present for the errors on (b)(6), but the photo memory would have been too large for your website to accept it.The has not caused me major damage, but on the dates when the free style device was indicating my glucose level was too low, when in fact it was correct, i have ingested glucose to raise my glucose level, meaning that my true glucose levels ended up being too high, which is a long term issue but still damaging.Fda safety report id # (b)(4).

• Brand Name: FREE STYLE LIBRE 14 DAY
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE, INC.
• MDR Report Key: 11700580
• MDR Text Key: 247007369
• Report Number: MW5100889
• Device Sequence Number: 1
• Product Code: PZE
• 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: 04/17/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2021
• Device Lot Number: 6155291
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 84