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

Model Number 71992-01

Device Problems Unable to Obtain Readings (1516); Failure to Deliver (2338)

Patient Problems Hyperglycemia (1905); Loss of consciousness (2418)

Event Date 01/31/2021

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device manufacturing date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A caller reported that the customer's freestyle libre 2 sensor had bent sensor tip, and therefore did not penetrate skin.The customer was unable to use sensor to obtain readings, and subsequently became fatigued, weak, and lost consciousness.The caller took the customer's blood glucose via capillary, and treated the customer with 8 ui insulin.The customer was then taken to the hospital where he was diagnosed with hyperglycemia, and given unspecified treatment via iv and medication.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Additional information, d4:( expiration date), d-4: (serial number), & h4: (device mfg date) have been updated, based on returned product.Sensor (b)(6) has been returned and investigated.Visual inspection has been performed on the returned sensor patch, and no issues were observed.Performed visual inspection on the applicator, and no damage was observed.The applicator had not been fired.And the sheath was locked.The sensor plug was not returned.No malfunction or product deficiency was identified.An extended investigation has also been performed for the reported complaint.There was no indication, that the product did not meet specifications.The dhrs (device history review) for the libre sensor and sensor kit were reviewed, and indicated that the libre sensor and sensor kits passed all tests prior to release.If the sensor plug is returned, an investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A caller reported, that the customer's freestyle libre 2 sensor had bent sensor tip.And therefore, did not penetrate skin.The customer was unable to use sensor to obtain readings.And subsequently, became fatigued, weak, and lost consciousness.The caller took the customer's blood glucose via capillary.And treated the customer with 8 ui insulin.The customer was then taken to the hospital, where he was diagnosed with hyperglycemia.And given unspecified treatment via iv and medication.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: 11368379
• MDR Text Key: 233190615
• Report Number: 2954323-2021-04952
• Device Sequence Number: 1
• Product Code: QLG
• 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: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2021
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 57