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

Model Number	70900-01
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	09/11/2018
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 higher than 500 mg/dl.A "hi" display message indicates a reading higher than 500 mg/dl.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A health care professional reported receiving a high reading from their adc hospital blood glucose meter.Customer reported a high reading of 500 mg/dl which was higher than a lab reading of 121 mg/dl.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 was returned and investigated with retained test strips.Visual inspection has been performed on the meter and no issues were observed.The complaint was not confirmed and no new issues were observed.All results were within range specification and no errors were observed during control solution testing.
Event or Problem Description
A health care professional reported receiving a high reading from their adc hospital blood glucose meter.Customer reported a high reading of 500 mg/dl which was higher than a lab reading of 121 mg/dl.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 test strips have not been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) for the precision strips were reviewed and the dhrs showed the precision strips passed all tests prior to release.Retain testing was performed for the precision strips indicated by the serial number provided by the customer and all units performed within specification.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 receiving a high reading from their (b)(6) hospital blood glucose meter.Customer reported a high reading of 500 mg/dl which was higher than a lab reading of 121 mg/dl.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 XCEED 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: 7916430
• Report Number: 2954323-2018-07307
• Device Sequence Number: 1449867
• Product Code: NBW
• UDI-Device Identifier: 00093815709329
• UDI-Public: 00093815709329
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K080960
• 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): 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 70900-01
• Device Lot Number: 4E6R5H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 01/10/2019; 12/03/2019
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 02/05/2019; 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1