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 Hypoglycemia (1912); Vertigo (2134); Discomfort (2330); Sweating (2444); Shaking/Tremors (2515)

Event Date 01/03/2019

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

Customer reported receiving an adc freestyle libre sensor scan result of ¿hi¿ (reading >500 mg/dl) and experiencing symptoms suggestive of hypoglycemia described as sweating, trembling, vertigo and discomfort.Someone other than the customer contacted a nurse via phone who advised a capillary test be performed.A reading of 41 mg/dl was obtained on the built-in reader and the customer was orally administered glucose (sugar water) for treatment by a third-party as customer was unable to self-treat.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product was returned for this complaint.Extended investigation was performed and determined that there was no indication that the product did not meet specification.The reported complaint does not pertain to libre readers.Therefore no further investigation into the reader will be required.Dhrs (device history review) for the libre sensor and libre sensor kit were reviewed and the dhrs showed the 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.

Event Description

Customer reported receiving an adc freestyle libre sensor scan result of ¿hi¿ (reading >500 mg/dl) and experiencing symptoms suggestive of hypoglycemia described as sweating, trembling, vertigo and discomfort.Someone other than the customer contacted a nurse via phone who advised a capillary test be performed.A reading of 41 mg/dl was obtained on the built-in reader and the customer was orally administered glucose (sugar water) for treatment by a third-party as customer was unable to self-treat.There was no report of death or permanent injury associated with this event.

• 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
• Manufacturer Contact: devin dirstine ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644391
• MDR Report Key: 8289789
• MDR Text Key: 134501307
• Report Number: 2954323-2019-00879
• 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: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• 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: 06/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2019
• 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: 26 YR
• Patient Weight: 72