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

Model Number	71702-01
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Codes	Nausea (1970); Shaking/Tremors (2515)
Date of Event	09/08/2018
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 customer reported receiving a sensor scan reading of 49 mg/dl on the adc freestyle libre and experiencing symptoms of shaking and nausea.The customer reported drinking "half a coke" and then going to the hospital due to the low reading.At the hospital a reading of 127 mg/dl was received on an unspecified hospital meter, compared to a reading of 92 mg/dl on the freestyle libre.The customer was given unspecified intravenous fluid at the hospital as treatment.There was no diagnosis provided and no further intervention or treatment reported.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
Additional information: reader (b)(4) has also been returned and investigated.Visual inspection of the returned reader (b)(4) has been performed and no issues were observed.Control solution testing has been performed on the returned reader and retained test strips.All results were within range specification and no errors were observed during control solution testing.Visual inspection of the reported sensor was performed and no issues were observed.Extracted data from the returned sensor using approved software.Sensor found to be in state 5 (normal termination).The sensor plug was visually inspected and the sensor plug was not properly seated in the mount.The complaint is not confirmed due to a use issue.No product deficiency was identified.
Event or Problem Description
A customer reported receiving a sensor scan reading of 49 mg/dl on the adc freestyle libre and experiencing symptoms of shaking and nausea.The customer reported drinking "half a coke" and then going to the hospital due to the low reading.At the hospital a reading of 127 mg/dl was received on an unspecified hospital meter, compared to a reading of 92 mg/dl on the freestyle libre.The customer was given unspecified intravenous fluid at the hospital as treatment.There was no diagnosis provided and no further intervention or treatment reported.There was no report of death or permanent injury 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: 7945308
• Report Number: 2954323-2018-07537
• Device Sequence Number: 19168324
• Product Code: PZE
• UDI-Device Identifier: 00357599000851
• UDI-Public: 00357599000851
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 11/19/2018

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: Lay User/Patient
• Device Model Number: 71702-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 11/19/2018
• 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 Weight: 87