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

Model Number 71562-01

Device Problem High Readings (2459)

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

Event Date 03/31/2017

Event Type  Injury  

Manufacturer Narrative

The customer¿s products have been requested for an investigation.A follow-up report will be filed once additional information is obtained.The device manufacturer date for the reported sensor serial number is unknown.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer (who is also a physician) reported that after 14 days of freestyle libre pro sensor wear, ¿he did not believe the device was reading accurately¿.The customer reported his average glucose profile from the libre pro sensor showed his blood glucose readings were ¿well over 250 mg/dl¿.He further reported that he had never had readings that high and that his normal blood glucose averages are ¿around 115 mg/dl¿.As a result of the high readings, the customer reported that on (b)(6) 2017 at 2 pm he injected himself with 4 units of humalog insulin and then went hiking with his wife.At 3 pm he reported he reportedly ¿blacked out¿ and experienced a loss of consciousness.The customer¿s wife (who is also a physician) gave her husband two glucose tablets, a glass of water, and a protein bar as treatment.The customer reported he performed a blood glucose test with his freestyle lite meter and received a reading of 39 mg/dl at an unspecified time after injecting the humalog insulin.No further treatment was reported.

Manufacturer Narrative

This report is being filed as a correction.Common device name was modified from "blood glucose monitoring system" to "flash glucose monitoring system.".

Manufacturer Narrative

The reported sensor was returned and investigated.Investigation of returned product did not identify product deficiencies.Investigation results determined there was no malfunction.Sensor test results were within range specification.The complaint is not confirmed.

Event Description

A customer (who is also a physician) reported that after 14 days of freestyle libre pro sensor wear, ¿he did not believe the device was reading accurately¿.The customer reported his average glucose profile from the libre pro sensor showed his blood glucose readings were ¿well over 250 mg/dl¿.He further reported that he had never had readings that high and that his normal blood glucose averages are ¿around 115 mg/dl¿.As a result of the high readings, the customer reported that on (b)(6) 2017 at 2 pm he injected himself with 4 units of humalog insulin and then went hiking with his wife.At 3 pm he reported he reportedly ¿blacked out¿ and experienced a loss of consciousness.The customer¿s wife (who is also a physician) gave her husband two glucose tablets, a glass of water, and a protein bar as treatment.The customer reported he performed a blood glucose test with his freestyle lite meter and received a reading of 39 mg/dl at an unspecified time after injecting the humalog insulin.No further treatment was reported.

Manufacturer Narrative

This serves as a correction report.(date received by manufacturer) was incorrectly documented in the mdr 30 day follow up #2 report.The correct date received by manufacturer date is may 11, 2017.

Event Description

A customer (who is also a physician) reported that after 14 days of freestyle libre pro sensor wear, ¿he did not believe the device was reading accurately¿.The customer reported his average glucose profile from the libre pro sensor showed his blood glucose readings were ¿well over 250 mg/dl¿.He further reported that he had never had readings that high and that his normal blood glucose averages are ¿around 115 mg/dl¿.As a result of the high readings, the customer reported that on (b)(6) 2017 at 2 pm he injected himself with 4 units of humalog insulin and then went hiking with his wife.At 3 pm he reported he reportedly ¿blacked out¿ and experienced a loss of consciousness.The customer¿s wife (who is also a physician) gave her husband two glucose tablets, a glass of water, and a protein bar as treatment.The customer reported he performed a blood glucose test with his freestyle lite meter and received a reading of 39 mg/dl at an unspecified time after injecting the humalog insulin.No further treatment was reported.

Manufacturer Narrative

This report serves as a correction.The following fields have been updated to reflect the correct information: unique identifier (udi) #, labeled for single use, and device mfg date.

Manufacturer Narrative

A device history record (dhr) review of the sensor was completed.The dhr for sensor serial (b)(4) indicated the device was performing within its performance claims and met the manufacturer's quality specifications prior to its release.(operator of device) was missing from the initial and mdr follow ups 1,2,3 and 4.Operator of device has been updated.

Event Description

A customer (who is also a physician) reported that after 14 days of freestyle libre pro sensor wear, ¿he did not believe the device was reading accurately¿.The customer reported his average glucose profile from the libre pro sensor showed his blood glucose readings were ¿well over 250 mg/dl¿.He further reported that he had never had readings that high and that his normal blood glucose averages are ¿around 115 mg/dl¿.As a result of the high readings, the customer reported that on (b)(6) 2017 at 2 pm he injected himself with 4 units of humalog insulin and then went hiking with his wife.At 3 pm he reported he reportedly ¿blacked out¿ and experienced a loss of consciousness.The customer¿s wife (who is also a physician) gave her husband two glucose tablets, a glass of water, and a protein bar as treatment.The customer reported he performed a blood glucose test with his freestyle lite meter and received a reading of 39 mg/dl at an unspecified time after injecting the humalog insulin.No further treatment was reported.

• Brand Name: FREESTYLE LIBRE PRO
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.; 1360 south loop road; alameda CA 94502 7001
• Manufacturer (Section G): ABBOTT DIABETES CARE INC.; 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: 6541345
• MDR Text Key: 74318481
• Report Number: 2954323-2017-03454
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71562-01
• Device Catalogue Number: 71562-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2017
• Initial Date FDA Received: 05/03/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 11/20/2017; 11/28/2017; 01/11/2018
• Supplement Dates FDA Received: 05/03/2017; 05/24/2017; 11/20/2017; 11/28/2017; 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention