MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71953-01

Device Problem Battery Problem (2885)

Patient Problems Fatigue (1849); Hypoglycemia (1912); Dizziness (2194)

Event Date 01/26/2023

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the freestyle libre reader were reviewed and the dhrs showed the freestyle libre reader passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A delivery delay with a replacement adc device was reported.The replacement device was issued due to the customer's adc reader only powering on with data cable.Customer additionally reported their reader "turns off by itself, and only with a lot of insistency does it turn on again, turns off immediately, no time to take readings." due to delivery delay, the customer could not monitor glucose levels and experienced "lack of strength" and dizziness, and was seen at a hospital where treatment of "package of sugar" and intravenous glucose was administered.There was no report of death or permanent injury associated with this event.

Event Description

A delivery delay with a replacement adc device was reported.The replacement device was issued due to the customer's adc reader only powering on with data cable.Customer additionally reported their reader "turns off by itself, and only with a lot of insistency does it turn on again, turns off immediately, no time to take readings." due to delivery delay, the customer could not monitor glucose levels and experienced "lack of strength" and dizziness, and was seen at a hospital where treatment of "package of sugar" and intravenous glucose was administered.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Reader (b)(6) has been returned and investigated.Visual inspection has been performed on the returned reader and no issues were observed.The reader did not turn on with the button press or with strip insertion.Reader powered on with universal serial bus (usb) cable insertion.Visually inspected the usb/charging cable and micro damage to the usb was observed.Performed a visual inspection on the returned adapter and no issues were observed.The power adapter passed the load testing and current voltage measured to be within specification.The reader was sent for further investigation and de-cased.The returned battery voltage was measured to be within specification.Placed returned reader into the reader printed circuit board assembly (pcba) test fixture and applied pressure to the central processing unit (cpu).The reader did power on with the button and battery was observed to be charging.An extended investigation was also performed on the reader.Performed a visual inspection on the returned reader and no abnormalities or damages were observed.Applied pressure to microcontroller processor (mcp); observed returned reader to power on.Therefore, this issue is confirmed due to poor soldering of the mcp.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 16383574
• MDR Text Key: 309635008
• Report Number: 2954323-2023-06971
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention