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 Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: (date of birth) has been updated to submit the mdr.The birth date listed in the case ((b)(6) 1899) is invalid.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 adc hospital blood glucose meter.Customer reported a high reading of 343 mg/dl which was higher than a lab reading of 129 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 was returned and investigated with retained strips.Visual inspection has been performed on the returned meter and no issues were observed.Control solution testing has been performed and no issues were observed.All results were within range specification and no errors were observed during control solution testing.No malfunction or product deficiency was identified.The reported test strips have not bee returned, an extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specifications.The dhrs (device history review) for the precision strips was reviewed.The dhrs showed the precision strips passed all tests prior to release.Retain testing was performed for precision strips and all units performed in the specification and passed.If the reported strips is returned, the case will be re-opened, and a physical investigation will be performed.
Event or Problem Description
A heath care professional reported a high reading from an adc hospital blood glucose meter.Customer reported a high reading of 343 mg/dl which was higher than a lab reading of 129 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: 8983391
• Report Number: 2954323-2019-06956
• Device Sequence Number: 16874396
• Product Code: NBW
• UDI-Device Identifier: 00093815712848
• UDI-Public: 00093815712848
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/24/2020

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: 71411-70
• Device Lot Number: 88MFPC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1