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

Model Number	98814-65
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	03/27/2020
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
Customer reported receiving erratic readings on their adc blood glucose meter.Customer reported receiving readings of 400 mg/dl and 90 mg/dl 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
No product has been returned.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 and precision xtra meter were reviewed and the dhrs showed the precision strips and precision xtra 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, a physical investigation will be performed and a follow-up report submitted.
Event or Problem Description
Customer reported receiving erratic readings on their adc blood glucose meter.Customer reported receiving readings of 400 mg/dl and 90 mg/dl 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
The reported meter ((b)(6)) was returned and investigated with retained test strips.Visual inspection was performed on the returned meter and no issues were observed.Meter powered on with button depression and insertion of retained strips.Control solution test was performed and results were satisfactory.No malfunction or product deficiency was identified.The reported test strips have not been returned, however an extended investigation for this complaint was previously completed and reported in the previous submission, therefore no further investigative actions are required.
Event or Problem Description
Customer reported receiving erratic readings on their adc blood glucose meter.Customer reported receiving readings of 400 mg/dl and 90 mg/dl 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: 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: 9963125
• Report Number: 2954323-2020-02716
• Device Sequence Number: 11592795
• Product Code: NBW
• UDI-Device Identifier: 00093815996941
• UDI-Public: 00093815996941
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 08/10/2020

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 Expiration Date: 03/31/2021
• Device Model Number: 98814-65
• Device Catalogue Number: 99694
• Device Lot Number: 4500182631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 05/06/2020; 07/15/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 06/02/2020; 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1