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

Model Number	71371-75
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	04/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The meter is designed to display readings of 20 mg/dl to 500 mg/dl.This meter does not show a numeric value less than 20 mg/dl.A blood glucose reading below 20 mg/dl will read as a "lo" in the adc meter.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Caller (customer¿s mother) reported the customer received erratic readings on their adc blood glucose meter.Readings of 475 mg/dl and "lo" (less than 20 mg/dl) were reportedly received within 10 minutes.The results when plotted on a parkes error grid 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
Since no product has been returned, extended investigation has been performed and determined that there was no indication that the product did not meet specification.Dhrs (device history review) for the freestyle precision neo meter and precision strips were reviewed and the dhrs showed the freestyle precision neo meter and precision strips passed all tests prior to release.As the strip lot associated with this case was past its expiry date of march 31, 2018 at the time of investigation, retain testing could not be performed.A tripped trend review was completed for the reported complaint and the freestyle precision neo meter.No trips were observed.A tripped trend review was completed for the reported complaint and precision test strips.No further track and trend review was required as there were no confirmed complaints.If the product is returned, the case will be re-opened and a physical investigation will be performed.
Event or Problem Description
Caller (customer¿s mother) reported the customer received erratic readings on their adc blood glucose meter.Readings of 475 mg/dl and "lo" (less than 20 mg/dl) were reportedly received within 10 minutes.The results when plotted on a parkes error grid 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 NEO
• 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: 6528413
• Report Number: 2954323-2017-03351
• Device Sequence Number: 13769870
• Product Code: NBW
• UDI-Device Identifier: 00093815715795
• UDI-Public: (01)00093815715795(17)20180331(10)4500168075
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K142928
• 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): 08/12/2018

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: Lay User/Patient
• Device Expiration Date: 03/31/2018
• Device Model Number: 71371-75
• Device Catalogue Number: 71579
• Device Lot Number: 4500168075
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2017
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 08/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 48