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

Model Number 75175-84

Device Problems Failure to Power Up (1476); Unable to Obtain Readings (1516)

Patient Problems Hypoglycemia (1912); Sweating (2444); Shaking/Tremors (2515)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The useful life of freestyle neo meter is 5 years.As the manufacturing date of this product is 2014, it has been in distribution beyond its useful life at the time of the complaint.Since the product exceeded its useful life, it is determined to have met specification when the product was released and through its lifespan.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reported being unable to test due to the adc blood glucose meter not powering on with button press or test strip insertion.Customer experienced sweating and "trembling in legs" and was unable to self-treat.Customer was treated with orange juice by a third party.No further treatment was reported.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE PRECISION NEO
• Type of Device: BLOOD 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: 10763362
• MDR Text Key: 213900177
• Report Number: 2954323-2020-09270
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K140371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 75175-84
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2014
• Is the Device Single Use?: No
• 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: 79 YR
• Patient Weight: 69