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

Model Number	71562-01
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A health care professional contacted adc to report that a tip of the sensor filament was left in the customer¿s arm on (b)(6) 2019.It was further reported that customer required medical attention for the removal of the sensor tip from the customer's arm.The hcp used sterile suture removing tweezers to extract the filament from a customer¿s arm.No further treatment or medication was required.There was no report of death or permanent impairment associated with this event.
Event or Problem Description
A health care professional contacted adc to report that a tip of the sensor filament was left in the customer¿s arm on (b)(6) 2019.It was further reported that customer required medical attention for the removal of the sensor tip from the customer's arm.The hcp used sterile suture removing tweezers to extract the filament from a customer¿s arm.No further treatment or medication was required.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
Additional information: section h4 has been updated based on product download sensor (b)(4) has been returned and investigated.Visual inspection has been performed on the returned sensor.Extracted data from returned sensor using approved software.Sensor found to be in state 5 (indicating normal termination).The sensor plug assembly was observed to be properly seated in mount.Sensor plug was removed, and a visual inspection was performed.Sensor neck crack was observed, which is indicative of an insertion failure.An extended investigation has also been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) for the libre sensor kit were reviewed and the dhrs showed the libre sensor kit passed all tests prior to release.Dose audit reports were reviewed and demonstrates the continued effectiveness of the established sterilization process for libre sensor kits.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.If the reported applicator and sensor pack are returned, the case will be re-opened, and a physical investigation will be performed.

• Brand Name: FREESTYLE LIBRE PRO
• 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: 8511669
• Report Number: 2954323-2019-02985
• Device Sequence Number: 16420093
• Product Code: MDS
• UDI-Device Identifier: 00357599715625
• UDI-Public: 00357599715625
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P150021
• 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): 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 71562-01
• Device Catalogue Number: 71562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention