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	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2018
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.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
Customer reported receiving erratic readings on their adc blood glucose meter.Customer reported receiving readings of 400 mg/dl, 114 mg/dl, 111 mg/dl and 500 mg/dl within 10 minutes.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 product's were returned and investigated.Visual inspection has been performed on the returned products and no issues were observed.The complaint was not confirmed and no new issues were observed.All results were within range specification and no errors were observed during control solution testing.
Event or Problem Description
Customer reported receiving erratic readings on their adc blood glucose meter.Customer reported receiving readings of 400 mg/dl, 114 mg/dl, 111 mg/dl and 500 mg/dl within 10 minutes.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: PRECISION XTRA
• 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: 7796894
• Report Number: 2954323-2018-06205
• Device Sequence Number: 1536289
• Product Code: NBW
• UDI-Device Identifier: 00093815996958
• UDI-Public: 00093815996958
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2018

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: 03/31/2019
• Device Model Number: 98814-65
• Device Lot Number: 4500169642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR