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

Model Number 71940-01

Device Problem High Readings (2459)

Patient Problems Hypoglycemia (1912); Weakness (2145); Pallor (2468); Shaking/Tremors (2515)

Event Date 07/10/2019

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

Caller reported a high readings issue with the adc freestyle libre that occurred between (b)(6) 2019 and (b)(6) 2019.The caller further reported that the customer received a sensor scan result of 489 mg/dl while experiencing symptoms described as "couldn't stand up, couldn't walk, shaking, cold, white, couldn't talk".The customer was taken to the emergency department where a blood glucose reading of 55 mg/dl was received on the hcp meter and unspecified hcp treatment was rendered.There was no report of death or permanent impairment 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.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.If the product is returned, the case will be re-opened and a physical investigation will be performed.

Event Description

Caller reported a high readings issue with the adc freestyle libre that occurred between (b)(6)2019 and (b)(6)2019.The caller further reported that the customer received a sensor scan result of 489 mg/dl while experiencing symptoms described as "couldn't stand up, couldn't walk, shaking, cold, white, couldn't talk".The customer was taken to the emergency department where a blood glucose reading of 55 mg/dl was received on the hcp meter and unspecified hcp treatment was rendered.There was no report of death or permanent impairment 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: tara williamson ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644472
• MDR Report Key: 8862185
• MDR Text Key: 153353144
• Report Number: 2954323-2019-05970
• Device Sequence Number: 1
• Product Code: PZE
• UDI-Device Identifier: 00357599001018
• UDI-Public: 00357599001018
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71940-01
• Device Catalogue Number: 71940
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2019
• 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 Weight: 93