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

Model Number	98814-65
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
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.The dhrs (device history review) for the fs libre reader were reviewed and the dhrs showed the fs libre reader passed all tests prior to release.The dhrs (device history review) 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 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
Customer reported receiving a high reading from their adc blood glucose meter.Customer reported a high reading of 14.4 mmol/l which was higher than a lab reading of 3.6 mmol/l.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
Reader (b)(6) has been returned and investigated with returned test strips.Visual inspection has been performed on the reader and no issues were observed.Meter powered on with button depression and strip insertion.Control solution testing was performed and no issues were performed.All results were within range specification.No malfunction or product deficiency was identified.Therefore the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer reported receiving a high reading from their adc blood glucose meter.Customer reported a high reading of 14.4 mmol/l which was higher than a lab reading of 3.6 mmol/l.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.

• Brand Name: PRECISION XTRA
• 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: 12911080
• Report Number: 2954323-2021-94076
• Device Sequence Number: 3510751
• Product Code: NBW
• UDI-Device Identifier: 00093815707455
• UDI-Public: 00093815707455
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K040814
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2022

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: Lay User/Patient
• Device Expiration Date: 08/31/2022
• Device Model Number: 98814-65
• Device Catalogue Number: 70745
• Device Lot Number: 75001J61
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2018
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: White