MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE FREEDOM LITE; BLOOD GLUCOSE MONITORING SYSTEM

Model Number	70914-70
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	12/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer's products have been requested for investigation.A follow-up report will be filed once the meter is returned or additional information is obtained.The date when the event occurred is unknown.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer¿s mother reported customer received high readings from his adc blood glucose meter.It was further reported that on an unspecified date/time customer received readings of ¿300 or higher¿ from his meter, which were higher than he felt.Paramedics were called and upon arrival received the following readings from their meter: 27 mg/dl, 43 mg/dl and 49 mg/dl.It is unknown how much time may have elapsed between the customer's and paramedic's results.Customer was treated with an intravenous infusion of d50, in addition to being given an unspecified ¿injection to bring his blood sugar back up¿.No further treatment was required.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
No product has been returned.Extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.Dhrs (device history review) for the freestyle freedom lite meter and freestyle strips were reviewed and the dhrs showed the freedom lite meter and freestyle strips passed all tests prior to release.Retain testing was performed for the freestyle strips and all units performed within specification and passed.All review activities conducted above, including but not limited to the final release testing specifically associated with the manufacture of this product, are sufficient information in order to show if the product has met specifications prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.
Event or Problem Description
Customer¿s mother reported customer received high readings from his adc blood glucose meter.It was further reported that on an unspecified date/time customer received readings of ¿300 or higher¿ from his meter, which were higher than he felt.Paramedics were called and upon arrival received the following readings from their meter: 27 mg/dl, 43 mg/dl and 49 mg/dl.It is unknown how much time may have elapsed between the customer's and paramedic's results.Customer was treated with an intravenous infusion of d50, in addition to being given an unspecified ¿injection to bring his blood sugar back up¿.No further treatment was required.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE FREEDOM LITE
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 7214422
• Report Number: 2954323-2018-00662
• Device Sequence Number: 1022912
• Product Code: NBW
• UDI-Device Identifier: 00699073708175
• UDI-Public: (01)00699073708175(10)1621503(17)180831
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K092602
• 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): 10/09/2018

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 Expiration Date: 08/31/2018
• Device Model Number: 70914-70
• Device Catalogue Number: 70817
• Device Lot Number: 1621503
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/26/2017
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 01/23/2018
• Supplement Report FDA Received Date: 10/09/2018
• 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