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

Model Number 71992-01

Device Problems Difficult to Insert (1316); Material Twisted/Bent (2981)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 05/14/2021

Event Type  Injury  

Manufacturer Narrative

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 libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits 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 customer reported the adc freestyle libre 2 sensor did not inset due to the " needle was bent." on (b)(6) 2021, the customer self-treated with 16 units of insulin and subsequently became hypoglycemic and had a loss of consciousness.The customer was found by her husband and encouraged to rest only.There was no third-party medical treatment reported.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor 3mh00489dah has been returned and investigated.Visual inspection was performed on the returned sensor and no issues were observed.The sensor plug was properly seated in the mount.A watermark was not observed at the base of the sensor tail (indicating that the sensor was never inserted).The sensor plug was removed and the plug assembly was inspected, no issues were observed.No issues were observed with the applicator (applicator had fired correctly), however damage to the sensor pack was observed, therefore this complaint is not confirmed to use due to incorrect assembly method.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported the adc freestyle libre 2 sensor did not inset due to the " needle was bent." on (b)(6) 2021, the customer self-treated with 16 units of insulin and subsequently became hypoglycemic and had a loss of consciousness.The customer was found by her husband and encouraged to rest only.There was no third-party medical treatment reported.There was no report of death or permanent injury associated with this event.

• 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
• MDR Report Key: 11848304
• MDR Text Key: 251401811
• Report Number: 2954323-2021-69740
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599800000
• UDI-Public: 00357599800000
• Combination Product (y/n): N
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2021
• Device Model Number: 71992-01
• Device Catalogue Number: 71992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 61