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

Model Number	98814-65
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	02/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported meter was returned for investigation.Performed visual inspection on the meter and no issues were observed.The meter powered on with button and test strip insertion.Control solution testing was performed.No error messages were observed, however the meter did not start after control solution was applied to retain test strips.The returned meter was de-cased.Performed visual inspection on the meter's pcb.Blood contamination was observed on the meter¿s test strips port.No product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A patrol officer reported that on (b)(6) 2018 at 11:00 a.M., a man was found unconscious.The patrol officer attempted to use the adc meter to test the man's glucose and was unsuccessful due to an er-3 message appearing on the meter display.Paramedics were called and upon their arrival at 11:15 a.M., a blood glucose result of 38 mg/dl was obtained on the paramedic meter and the man was treated with d-50 glucose via intravenous infusion.Once he regained consciousness, he was provided solid food and transported to a hospital at 11:40 a.M.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
This serves as a correction report as date received by mfg was incorrectly documented in the previous report.The correct date received by mfg date is 2/20/2018.(pma/510(k)) was also incorrectly documented.Pma/510(k) has been updated.
Event or Problem Description
A patrol officer reported that on (b)(6) 2018 at 11:00 a.M., a man was found unconscious.The patrol officer attempted to use the adc meter to test the man's glucose and was unsuccessful due to an er-3 message appearing on the meter display.Paramedics were called and upon their arrival at 11:15 a.M., a blood glucose result of 38 mg/dl was obtained on the paramedic meter and the man was treated with d-50 glucose via intravenous infusion.Once he regained consciousness, he was provided solid food and transported to a hospital at 11:40 a.M.There was no report of death or permanent impairment 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: 7301716
• Report Number: 2954323-2018-01688
• Device Sequence Number: 16600948
• Product Code: NBW
• UDI-Device Identifier: 00093815801160
• UDI-Public: (01)00093815801160(17)20181231(10)4500169217
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2018

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: Other
• Device Model Number: 98814-65
• Device Catalogue Number: 80116
• Device Lot Number: 4500169217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 12/06/2018
• 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: 66 YR
• Patient Weight: 68