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

Model Number	71525-01
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	04/04/2019
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 date of event 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 customer reported that she was unable to test due to her adc freestyle libre reader not powering on with button press or test strip insertion, because the reader wouldn't charge.Customer further reported that she felt ill, so she went to the emergency room.The customer was administered insulin (unspecified route) for treatment.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
The reported reader was returned and investigated and a new issue was observed.Visual inspection has been performed on the returned reader and no issues were observed.The reader turned on with button depression and an error 2 was observed.A blank screen was not observed.Further investigation has been performed and the reader was de-cased.It was confirmed that the error 2 is isolated to the reader's cpu (central processing unit).Although glucose results may be delayed, blood glucose could be determined by alternate means, including use of another blood glucose meter, seeing a physician (as recommended in product labeling), or by seeking treatment at a health care facility.
Event or Problem Description
A customer reported that she was unable to test due to her adc freestyle libre reader not powering on with button press or test strip insertion, because the reader wouldn't charge.Customer further reported that she felt ill, so she went to the emergency room.The customer was administered insulin (unspecified route) for treatment.There was no report of death or permanent impairment 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: 8552902
• Report Number: 2954323-2019-03367
• Device Sequence Number: 18925714
• Product Code: PZE
• UDI-Device Identifier: 00357599000219
• UDI-Public: 00357599000219
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 06/17/2019

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: Lay User/Patient
• Device Model Number: 71525-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 06/17/2019
• 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: 42 YR