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

Model Number	71411-70
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	07/08/2020
Type of Reportable Event	Malfunction
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 specification.Dhrs for the precision test strips were reviewed and the dhrs showed the precision test strips passed all tests prior to release.Retain testing was performed for precision strips and all units performed in specification and passed.The useful life of freestyle precision pro meter is 5 years.As the manufacturing date of this product is 2011, it has been in distribution beyond its useful life.Therefore, no further investigation activities are required.The date entered is the date abbott diabetes care became aware of the event.If the product is returned, the case will be re-opened and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A health care professional reported that a patient received a low reading from an adc hospital blood glucose meter.The health care professional reported a low reading of 492 mg/dl which was lower than lab reading of 678 mg/dl.The results when plotted on a parkes error grid fell "out of range" 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 upon docking.Control solution tests were performed and all 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 at this time.If the test strips are returned, the case will be re-opened and a physical investigation will be performed.
Event or Problem Description
A health care professional reported that a patient received a low reading from an adc hospital blood glucose meter.The health care professional reported a low reading of 492 mg/dl which was lower than lab reading of 678 mg/dl.The results when plotted on a parkes error grid fell "out of range" 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: 10337918
• Report Number: 2954323-2020-05086
• Device Sequence Number: 2259240
• Product Code: NBW
• UDI-Device Identifier: 00093815709329
• UDI-Public: 00093815709329
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132511
• 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
• Report Date (Section B): 09/03/2020

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: Health Professional
• Device Model Number: 71411-70
• Device Catalogue Number: 70932
• Device Lot Number: 4H245H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1