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

Model Number	98814-65
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Loss of consciousness (2418); Diaphoresis (2452)
Date of Event	09/17/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
A healthcare provider reported that on (b)(6) 2018 at 5pm a clinic¿s adc blood glucose meter would turn on with button press, but not with test strip insertion, thereby preventing a reading from being obtained.It was further reported the customer/patient became ¿hypertensive, diaphoretic¿, and subsequently ¿lost consciousness¿.Paramedics were called and upon arrival received a reading of 20 mg/dl on their meter and transported him to a hospital.Caller did not know the specific treatment rendered by the paramedics or at the hospital.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
The reported meter has been returned and investigated with retained test strips.The meter powered on with button depression.Meter did not power on with strip insertion.The meter was sent for further investigation and dissembled.Performed visual inspection on circuit board and no issues were observed.Performed visual inspection on port pins and observed evidence of blood under the port pins.The complaint is not confirmed due to a use issue.This also serves as a correction report.Meter brand name and pma510k# were incorrectly documented in the initial mdr 30 day report.Both sections have been updated.
Event or Problem Description
A healthcare provider reported that on (b)(6) 2018 at 5pm a clinic¿s adc blood glucose meter would turn on with button press, but not with test strip insertion, thereby preventing a reading from being obtained.It was further reported the customer/patient became ¿hypertensive, diaphoretic¿, and subsequently ¿lost consciousness¿.Paramedics were called and upon arrival received a reading of 20 mg/dl on their meter and transported him to a hospital.Caller did not know the specific treatment rendered by the paramedics or at the hospital.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
The reported test strips have not been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) for the precision strips were reviewed and the dhrs showed the precision strips passed all tests prior to release.Retain testing was performed for the precision strips and all units performed within specification.If the test strips are returned, the case will be re-opened, and a physical investigation will be performed.
Event or Problem Description
A healthcare provider reported that on (b)(6) 2018 at 5pm a clinic¿s adc blood glucose meter would turn on with button press, but not with test strip insertion, thereby preventing a reading from being obtained.It was further reported the customer/patient became ¿hypertensive, diaphoretic¿, and subsequently ¿lost consciousness¿.Paramedics were called and upon arrival received a reading of 20 mg/dl on their meter and transported him to a hospital.Caller did not know the specific treatment rendered by the paramedics or at the hospital.There was no report of death or permanent injury associated with this event.

• Brand Name: PRECISION XTRA
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 7971963
• Report Number: 2954323-2018-07777
• Device Sequence Number: 11197446
• Product Code: NBW
• UDI-Device Identifier: 00093815801160
• UDI-Public: 00093815801160
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Model Number: 98814-65
• Device Lot Number: 4500180372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 12/20/2018; 12/04/2019
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 01/15/2019; 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 57