MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE PRECISION 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	Hyperglycemia (1905)
Date of Event	10/05/2020
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
A health care professional reported a high reading from an hospital adc blood glucose meter.The health care professional reported a high reading of 234 mg/dl which was higher than a lab reading of 104 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 strips.Visual inspection has been performed on the returned meter and no issues were observed.Meter powered on with button and upon docking.Control solution testing has been performed and all results were within range specification.No malfunction or product deficiency was identified.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 pro meter were reviewed and the dhrs showed the freestyle pro meter passed all tests prior to release.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.If the partial 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 a high reading from an hospital adc blood glucose meter.The health care professional reported a high reading of 234 mg/dl which was higher than a lab reading of 104 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: FREESTYLE PRECISION 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: 10712161
• Report Number: 2954323-2020-07730
• Device Sequence Number: 14249398
• Product Code: NBW
• UDI-Device Identifier: 00093815712848
• UDI-Public: 00093815712848
• 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: consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

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: 71284
• Device Lot Number: 8975P0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1