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

Model Number	71411-70
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been requested back for investigation.A follow- up report will be submitted once additional information is obtained.Note: the meter is designed to report readings of 20 mg/dl to 500 mg/dl.It should be noted that this meter does not give numeric value for readings less than 20 mg/dl.A "lo" display message indicates a reading less than 20 mg/dl.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A health professional reported receiving erratic readings on an adc blood glucose meter within 10 minutes.Results of 387 mg/dl, 75 mg/dl and "lo" (a reading less than 20 mg/dl) were plotted on the parkes error grid.The results fell into the "c" zone showing the difference in values to be clinically significant.There was no report of death, serious injury or mistreatment associated with this event.
Additional Manufacturer Narrative
This serves as a correction report.(date returned to mfg) was incorrectly documented in the previous follow up report.Has been updated.
Event or Problem Description
A health professional reported receiving erratic readings on an adc blood glucose meter within 10 minutes.Results of 387 mg/dl, 75 mg/dl and "lo" (a reading less than 20 mg/dl) were plotted on the parkes error grid.The results fell into the "c" zone showing the difference in values to be clinically significant.There was no report of death, serious injury or mistreatment associated with this event.
Additional Manufacturer Narrative
Performed visual inspection on returned meter and no issues were observed.Returned meter powered on with button depression and upon docking.Control solution testing was performed and results were satisfactory.No product deficiency was identified.
Event or Problem Description
A health professional reported receiving erratic readings on an adc blood glucose meter within 10 minutes.Results of 387 mg/dl, 75 mg/dl and "lo" (a reading less than 20 mg/dl) were plotted on the parkes error grid.The results fell into the "c" zone showing the difference in values to be clinically significant.There was no report of death, serious injury or mistreatment associated with this event.

• Brand Name: FREESTYLE PRECISION PRO
• 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: 7233018
• Report Number: 2954323-2018-00779
• Device Sequence Number: 1826369
• Product Code: NBW
• UDI-Device Identifier: 00093815712848
• UDI-Public: (01)00093815712848(17)20181231(10)86CVPC
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K132511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 71411-70
• Device Catalogue Number: 71284
• Device Lot Number: 86CVPC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Initial Date Received by Manufacturer: 01/16/2018
• Supplement Date Received by Manufacturer: 03/27/2018; 12/05/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 03/29/2018; 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1