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

Model Number	70932-01
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reports that a patient received a low reading from an adc hospital blood glucose meter.The health care professional reported a low reading of 164 mg/dl which was lower than a lab reading of 547 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
No product has been returned, extended investigation is pending at this time.A follow- up report will be submitted once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
Additional Manufacturer Narrative
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.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 specification.Dhrs for the freestyle precision pro meter were reviewed and the dhrs showed the freestyle precision pro meter passed all tests prior to release.Dhrs for the precision strips were reviewed and the dhrs showed the precision strips passed all tests prior to release.Retain testing was performed for precision strips and all units performed in specification and passed.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A health care professional reports that a patient received a low reading from an adc hospital blood glucose meter.The health care professional reported a low reading of 164 mg/dl which was lower than a lab reading of 547 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 has been returned and investigated with retained test strip.Visual inspection has been performed on the returned meter and no issues were observed.Meter powered on with button and upon docking.Performed meter power up/self-test sequence with no issues observed.Control solution testing has been performed and all results were within range specification.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A health care professional reports that a patient received a low reading from an adc hospital blood glucose meter.The health care professional reported a low reading of 164 mg/dl which was lower than a lab reading of 547 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
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 13172142
• Report Number: 2954323-2022-00434
• Device Sequence Number: 17183273
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2022

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: 06/30/2022
• Device Model Number: 70932-01
• Device Catalogue Number: 70932
• Device Lot Number: 4J535H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2022
• Supplement Date Received by Manufacturer: 02/11/2022; 04/01/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 02/14/2022; 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown