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

Model Number	70900-01
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2017
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.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A healthcare professional reported receiving inaccurately high readings on the adc blood glucose meter.Health professional reported receiving meter readings of 227 mg/dl and 278 mg/dl compared to a lab result of 93 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.The reported readings were obtained from a patient experiencing medical issues unrelated to diabetes.The reported issue did not cause or contribute to a death, serious injury or mistreatment.
Additional Manufacturer Narrative
Since no product has been returned, extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.Dhrs (device history review) for the xceed precision pro meter and precision pro (g3ch) strips were reviewed, and the dhrs showed the precision pro meter and strips passed all tests prior to release.As the strip lot associated with this case was past its expiry date of 30 apr 2018 at the time of investigation, retain testing could not be performed.A tripped trend review was completed for the reported complaint, precision pro meter and precision pro test strips.No trips were observed.If the product is returned, the case will be re-opened and a physical investigation will be performed.
Event or Problem Description
A healthcare professional reported receiving inaccurately high readings on the adc blood glucose meter.Health professional reported receiving meter readings of 227 mg/dl and 278 mg/dl compared to a lab result of 93 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.The reported readings were obtained from a patient experiencing medical issues unrelated to diabetes.The reported issue did not cause or contribute to a death, serious injury or mistreatment.
Additional Manufacturer Narrative
The reported meter was returned and investigated.Performed visual inspection on returned meter.No issues were observed upon visual inspection.A new issue was observed upon docking.The meter was sent for further investigation and de-cased.Observed dry spots from liquid ingress inside of docking port upon internal visual inspection.Issue is not confirmed due to a user issue.
Event or Problem Description
A healthcare professional reported receiving inaccurately high readings on the adc blood glucose meter.Health professional reported receiving meter readings of 227 mg/dl and 278 mg/dl compared to a lab result of 93 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.The reported readings were obtained from a patient experiencing medical issues unrelated to diabetes.The reported issue did not cause or contribute to a death, serious injury or mistreatment.

• 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: 6877729
• Report Number: 2954323-2017-06495
• Device Sequence Number: 1405970
• Product Code: NBW
• UDI-Device Identifier: 00093815709329
• UDI-Public: (01)00093815709329(17)20180430(10)4C3V5H
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 07/10/2019

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: 04/30/2018
• Device Model Number: 70900-01
• Device Catalogue Number: 70932
• Device Lot Number: 4C3V5H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 07/13/2018; 06/12/2019
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 08/08/2018; 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR