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

Model Number 71702-01

Device Problem High Readings (2459)

Patient Problems Fainting (1847); Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 10/08/2018

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 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 caller reported that a customer obtained higher readings from an adc freestyle libre sensor compared to the built-in meter.On (b)(6) 2018 at 1200, the caller stated that the customer obtained a higher unspecified reading from his reader compared to the built-in meter.The customer was treated with insulin (type/dose unknown) based "to" the higher readings from the sensor and fainted and had loss of consciousness.Contact was made with an hcp that treated customer with an unspecified "sugar solution" intravenously.Within 15 minutes of the medical intervention, the customers blood glucose level is 12mmol/l (216mg/dl), obtained on a unspecified meter.The customer was diagnosed with hypoglycemia.There was no report of death or permanent injury associated with this event.

Event Description

A caller reported that a customer obtained higher readings from an adc freestyle libre sensor compared to the built-in meter.On (b)(6) 2018 at 1200, the caller stated that the customer obtained a higher unspecified reading from his reader compared to the built-in meter.The customer was treated with insulin (type/dose unknown) based to the higher readings from the sensor and fainted and had loss of consciousness.Contact was made with an hcp that treated customer with an unspecified "sugar solution" intravenously.Within 15 minutes of the medical intervention, the customers blood glucose level is 12mmol/l (216mg/dl) obtained on a unspecified meter.The customer was diagnosed with hypoglycemia.There was no report of death or permanent injury associated with this event.

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 (device history review) 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.

• Brand Name: FREESTYLE LIBRE
• 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: 8107240
• MDR Text Key: 128452523
• Report Number: 2954323-2018-09050
• 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,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71702-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention