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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2020
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.Note: the meter is designed to report readings of 20 mg/dl to 500 mg/dl.It should be noted that this meter does not give numeric value for readings higher than 500 mg/dl.A "hi" display message indicates a reading higher than 500 mg/dl.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A health care professional reported erratic readings from an adc hospital blood glucose meter.The health care professional reported readings of 500 mg/dl and 29 mg/dl within 10 minutes.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.
Event or Problem Description
A health care professional reported erratic readings from an adc hospital blood glucose meter.The health care professional reported readings of 500 mg/dl and 29 mg/dl within 10 minutes.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 reported meter was returned and investigated with returned test strips.Performed visual inspection on returned meter and no issue was observed.The meter powered on with button press and upon docking.A control solution test was performed and passed.All results were within range specification, therefore, it is not confirmed.Extended investigation has also been performed for the reported complaint and there was no indication that the product did not meet specification.A dhr (device history review) for the freestyle precision pro meter was reviewed and the dhr showed the freestyle precision pro meter passed all tests prior to release.A dhr for the precision strips was reviewed and the dhr showed the precision strips passed all tests before release.Retain testing was performed for the precision strips and all units performed within specification.If the product is returned, the case will be re-opened and a physical investigation will be performed.

• 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: 10573911
• Report Number: 2954323-2020-06484
• Device Sequence Number: 2627386
• Product Code: NBW
• UDI-Device Identifier: 00093815712848
• UDI-Public: 00093815712848
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/10/2020

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: 88A8PC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1