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	Hypoglycemia (1912)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported a patient received high readings from their adc hospital device.The health care professional reported high readings of 134 mg/dl and 134 mg/dl which were higher than lab reading of 34 mg/dl and 39 mg/dl.The results when plotted on a parkes error grid fell into the "d" 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 customer¿s product has been requested for investigation.A follow-up report will be filed 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 patient received high readings from their adc hospital device.The health care professional reported high readings of 134 mg/dl and 134 mg/dl which were higher than lab reading of 34 mg/dl and 39 mg/dl.The results when plotted on a parkes error grid fell into the "d" 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
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned as of this report.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 and precision strips were reviewed and the dhrs showed the freestyle precision pro meter and precision strips passed all tests prior to release.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 reported a patient received high readings from their adc hospital device.The health care professional reported high readings of 134 mg/dl and 134 mg/dl which were higher than lab reading of 34 mg/dl and 39 mg/dl.The results when plotted on a parkes error grid fell into the "d" 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
Meter (b)(6) has been returned and visual inspection performed.No issues were observed.Installed retained batteries.Meter powered on with button depression.Observed lcd during power up/ self-test sequence, no issues observed.Control solution testing has been performed and all results were within range specification.No malfunction or product deficiency was identified.Therefore, this issue is not confirmed.If the reported test strips are returned, an investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.

• 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
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 15744489
• Report Number: 2954323-2022-40685
• Device Sequence Number: 20586883
• Product Code: NBW
• UDI-Device Identifier: 00093815712848
• UDI-Public: 00093815712848
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K132511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2023

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: 01/31/2023
• Device Model Number: 71411-70
• Device Catalogue Number: 71284
• Device Lot Number: 8C01P0
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 11/21/2022; 03/23/2023
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 12/05/2022; 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2021
• 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