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	02/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported product has been returned and is pending investigation.A follow-up report will be filed once additional information is obtained.The date of manufacture is unknown.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A nurse and an adc sales representative reported that on (b)(6) 2018 while the health care provider (hcp) was going through the normal insertion process with a patient the adc freestyle libre sensor failed to activate so the hcp removed the sensor.Upon removal of the sensor it was discovered that the sharp had remained in the patient¿s arm.The hcp removed the sharp from the patient¿s arm, treated the area prophylactically with an unspecified ¿antibiotic ointment¿ and bandaged the wound.The patient was also advised to take ibuprofen for any pain and/or swelling.No additional treatment was reported.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
Performed visual inspection on returned sensor and no issues were observed.Sensor data extraction was successful.Sensor was found to be in state 1 (storage state).Since the applicator and sensor pack was not returned, extended investigation has been performed.Investigated for the insertion-6 complaint has determined that there was no indication that the product did not meet specification.Sensor kit dhrs have been reviewed to assess the manufacturing process, and no anomalies were found that affected insertion of the sensor via the sharp.As this complaint relates to the sharp, dose audit reports and environmental monitoring have not been reviewed since the complaint is a sharp insertion issue, and not related to sterility, bioburden, or endotoxin issues.A tripped trend review was completed and shows no trips for insertion-6 and libre pro sensors.
Event or Problem Description
A nurse and an adc sales representative reported that on (b)(6) 2018 while the health care provider (hcp) was going through the normal insertion process with a patient the adc freestyle libre sensor failed to activate so the hcp removed the sensor.Upon removal of the sensor it was discovered that the sharp had remained in the patient¿s arm.The hcp removed the sharp from the patient¿s arm, treated the area prophylactically with an unspecified ¿antibiotic ointment¿ and bandaged the wound.The patient was also advised to take ibuprofen for any pain and/or swelling.No additional treatment was reported.There was no report of death or permanent injury associated with this event.

• 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: 7363640
• Report Number: 2954323-2018-02318
• Device Sequence Number: 107109
• Product Code: MDS
• UDI-Device Identifier: 00357599715625
• UDI-Public: (01)00357599715625(17)180331(10)170731A
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2018

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: 03/09/2018
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 05/10/2018
• 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
• Patient Age: 72 YR
• Patient Weight: 95