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	05/04/2020
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.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 60 mg/dl, 60 mg/dl, 115 mg/dl and 207 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
No product has been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specifications.The dhrs (device history review) for the libre reader and precision strips were reviewed.The dhrs showed the libre reader and precision strips passed all tests prior to 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.
Event or Problem Description
Customer reported receiving erratic readings from their adc freestyle libre built in meter.Customer reported receiving readings of 60 mg/dl, 60 mg/dl, 115 mg/dl and 207 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.
Event or Problem Description
Customer reported receiving erratic readings from their adc freestyle libre built in meter.Customer reported receiving readings of 60 mg/dl, 60 mg/dl, 115 mg/dl and 207 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 (b)(4) has been returned and investigated with retained test strips as the returned test strips were expired.Visual inspection has been performed on the returned meter and no issues were observed.Control solution testing has been performed with retained test strips and no issues were observed.All results were within range specification.No malfunction or product deficiency was identified.

• 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: 10057619
• Report Number: 2954323-2020-03387
• Device Sequence Number: 10956584
• Product Code: PZE
• UDI-Device Identifier: 00093815715795
• UDI-Public: 00093815715795
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 07/21/2020

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: Lay User/Patient
• Device Expiration Date: 05/31/2020
• Device Model Number: 71938-01
• Device Catalogue Number: 71579
• Device Lot Number: 4500181464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2020
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 06/05/2020; 06/26/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 06/26/2020; 07/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR