MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE; FLASH GLUCOSE MONITORING SYSTEM

Model Number	71938-01
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	02/28/2019
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.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer reported receiving erratic readings from their adc freestyle libre built-in meter.Customer reported receiving readings of 32 mg/dl and 230 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 reader and one reported test strip has been returned and investigated, a new issue was observed.Visual inspection has been performed on the returned meter and strip, no issues were observed.A built in reader test was successfully performed.Control solution testing has been performed using the returned reader and the returned test strip, an error 3 was observed during control solution testing.Mix match testing has been performed using the returned reader and retained test strips and all test results were within satisfactory range.Extended investigation has also been performed and a dhr (device history review) was performed on the reported test strips, no issues were observed.Retain testing has been performed and all units performed within specification and passed.No malfunction or product deficiency was identified.
Event or Problem Description
Customer reported receiving erratic readings from their adc freestyle libre built-in meter.Customer reported receiving readings of 32 mg/dl and 230 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: FREESTYLE LIBRE
• Common Device Name: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 8438047
• Report Number: 2954323-2019-02327
• Device Sequence Number: 11507742
• Product Code: PZE
• UDI-Device Identifier: 00093815715795
• UDI-Public: 00093815715795
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160030
• 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): 07/29/2019

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: 12/31/2019
• Device Model Number: 71938-01
• Device Catalogue Number: 71938-01
• Device Lot Number: 4500180748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 07/05/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR