MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LITE; BLOOD GLUCOSE MONITORING SYSTEM

Model Number 71501-01

Device Problem Data Problem (3196)

Patient Problems Hypoglycemia (1912); Blurred Vision (2137); Sweating (2444); Shaking/Tremors (2515); Confusion/ Disorientation (2553)

Event Date 01/07/2019

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 date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.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 being unable to test with her adc blood glucose meter as she was not able to set up the right time and date.Customer further reported experiencing symptoms described as ¿blurred vision, hands shaking, sweating, eyes shifting, disoriented" and was unable to self-treat.Customer was treated with jelly by her daughters and paramedics were called, who obtained a reading of 111 mg/dl.No medication was administered by the paramedics and was advised to report the incident to her doctor.Customer self-treated with a candy bar after the paramedics left.There was no report of death or permanent impairment associated with this event.

Event Description

Customer reported being unable to test with her adc blood glucose meter as she was not able to set up the right time and date.Customer further reported experiencing symptoms described as ¿blurred vision, hands shaking, sweating, eyes shifting, disoriented" and was unable to self-treat.Customer was treated with jelly by her daughters and paramedics were called, who obtained a reading of 111 mg/dl.No medication was administered by the paramedics and was advised to report the incident to her doctor.Customer self-treated with a candy bar after the paramedics left.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 there was no indication that the product did not meet specification.  a (dhr) (device history review) for the freestyle lite meter was reviewed, and the dhr showed the freestyle lite meter 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 LITE
• Type of Device: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 8267783
• MDR Text Key: 133755784
• Report Number: 2954323-2019-00645
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K092602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71501-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 100