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	03/03/2019
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.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A health care professional reported that a patient received a high reading from a hospital adc blood glucose meter.A health care professional reported a reading of 400 mg/dl which was higher than a lab reading of 72 mg/dl.The results when plotted on a parkes error grid fell into the "d" 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
At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specifications.Dhrs (device history review) for the precision strips was reviewed.The dhrs showed the precision strips passed all tests prior to release.The dhrs for the freestyle precision pro meter was reviewed.The dhrs showed the freestyle precision pro meter passed all tests prior to release.Retain testing was performed for precision strips and all units performed in the specification and passed.If the product is returned, the case will be re-opened, and a physical investigation will be performed.
Event or Problem Description
A health care professional reported that a patient received a high reading from a hospital adc blood glucose meter.A health care professional reported a reading of 400 mg/dl which was higher than a lab reading of 72 mg/dl.The results when plotted on a parkes error grid fell into the "d" 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: 8474679
• Report Number: 2954323-2019-02704
• Device Sequence Number: 1474526
• Product Code: NBW
• UDI-Device Identifier: 00093815712848
• UDI-Public: 00093815712848
• 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: consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

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: Lay User/Patient
• Device Model Number: 71411-70
• Device Catalogue Number: 71411-70
• Device Lot Number: 87VKPC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1