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

Model Number 98814-65

Device Problem Product Quality Problem (1506)

Patient Problems Hypoglycemia (1912); Dizziness (2194); Sweating (2444)

Event Date 11/07/2020

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.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer's mother initially reported the battery contacts of the adc meter were broken.A replacement product was ordered and on (b)(6) 2020, the caregiver reported that due to a delivery issue involving the replacement product, customer was unable to test and experienced symptoms described as clammy, sweaty, dizziness, and "twirly".Customer was taken to a hospital where his blood glucose was determined to be 50 mg/dl and he was treated for hypoglycemia.Caller could not recall the specific medication but presumed it to be insulin.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A tripped trend review was completed for the reported complaint and xceed meter, and there were no adverse trends that indicate any potential product-related issues.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.Section d4 (serial number) has been updated from (b)(6)unknown as the serial number was deemed invalid during the investigation.

Event Description

Customer's mother initially reported the battery contacts of the adc meter were broken.A replacement product was ordered and on (b)(6)-2020, the caregiver reported that due to a delivery issue involving the replacement product, customer was unable to test and experienced symptoms described as clammy, sweaty, dizziness, and "twirly".Customer was taken to a hospital where his blood glucose was determined to be 50 mg/dl and he was treated for hypoglycemia.Caller could not recall the specific medication but presumed it to be insulin.There was no report of death or permanent injury associated with this event.

• Brand Name: PRECISION XTRA
• 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: 10936645
• MDR Text Key: 219313466
• Report Number: 2954323-2020-12580
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K040814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

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: Lay User/Patient
• Device Model Number: 98814-65
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention