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

Model Number 98814-65

Device Problem No Display/Image (1183)

Patient Problems Hyperglycemia (1905); Unspecified Infection (1930)

Event Date 04/19/2019

Event Type  Injury  

Manufacturer Narrative

The customer's products have been requested for investigation.A follow-up report will be filed once the product is returned or additional information is obtained.The date of manufacture is unknown.The date listed is the date when abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reported that on (b)(6) 2019 her adc blood glucose meter¿s system check screen displayed ¿666'' instead of ''888¿, noting the last time she used her meter was on (b)(6) 2019.She further reported that on (b)(6) 2019 she was taken to an emergency room, with symptoms of a ¿headache, losing her sense of balance and pain¿.Customer noted the symptoms started approximately one week prior to going to the hospital.At the hospital, a reading of 300 mg/dl was received on an unspecified hospital device, customer was diagnosed with a bladder infection and hyperglycemia and treated with an unspecified amount of insulin.Customer was also started on glipizide.It is unknown what specific treatment was rendered for the bladder infection.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

At this time product has not yet been returned.As the manufacturing date of the reported meter is before 2010, it has been determined that the product exceeded its useful life.It is determined to have met specifications when the product was released and through its lifespan.Therefore, no further investigation activities are required.If the product is returned, the case will be re-opened and a physical investigation will be performed.

Event Description

Customer reported that on (b)(6)2019 her adc blood glucose meter¿s system check screen displayed ¿666 instead of 888¿, noting the last time she used her meter was on (b)(6)2019.She further reported that on (b)(6)2019 she was taken to an emergency room, with symptoms of a ¿headache, losing her sense of balance and pain¿.Customer noted the symptoms started approximately one week prior to going to the hospital.At the hospital, a reading of 300 mg/dl was received on an unspecified hospital device, customer was diagnosed with a bladder infection and hyperglycemia and treated with an unspecified amount of insulin.Customer was also started on glipizide.It is unknown what specific treatment was rendered for the bladder infection.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
• Manufacturer Contact: devin dirstine ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644472
• MDR Report Key: 8629208
• MDR Text Key: 145682867
• Report Number: 2954323-2019-04075
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070984
• 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: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• 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
• Date Manufacturer Received: 01/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2019
• 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: 47 YR
• Patient Weight: 112