MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71940-01

Device Problem Low Readings (2460)

Patient Problems Headache (1880); Hyperglycemia (1905); Vertigo (2134)

Event Date 09/07/2019

Event Type  Injury  

Manufacturer Narrative

No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The reported complaint does not pertain to the freestyle libre reader.Therefore no further investigation into the reader is required.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.All review activities conducted above, including but not limited to the final release testing specifically associated with the manufacture of this product, are sufficient information in order to show if the product has met specifications prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.The device mfg 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 low readings issue was reported with the adc freestyle libre sensor.Customer reported receiving a message 'lo' (reading less than 40 mg/dl) on the sensor and experiencing headache and vertigo.Customer self-treated with novorapid insulin (dose unknown) and called emergency services, who transported him to a hospital.At the hospital, a reading of 800 mg/dl was obtained on the hospital device and customer was diagnosed with hyperglycemia and treated with "3 perfusions to rehydrate" and insulin.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE 14 DAY
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: devin dirstine ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644391
• MDR Report Key: 9153926
• MDR Text Key: 161177930
• Report Number: 2954323-2019-07623
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71940-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 95