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

Model Number	71371-75
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Codes	Fatigue (1849); Lethargy (2560); Polydipsia (2604)
Date of Event	01/18/2017
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.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer¿s mother reported customer received a reading from his adc blood glucose meter which was lower than a subsequent reading obtained at the hospital.Caller further reported that on (b)(6) 2017 customer received a reading of ¿lo¿ (a reading less than 20 mg/dl) at 8:00 am and noted he was experiencing ¿fatigue, extreme thirst, was hungry and sleepy¿.Customer then ate breakfast, while caller contacted customer¿s healthcare provider via phone.Caller was instructed to bring the customer to the hospital.At the hospital, a reading of 500 mg/dl was received at 10:30 am from a hospital meter.Customer was hospitalized, diagnosed with hyperglycemia and treated with insulin via intravenous infusion.Customer remained in the hospital for four days while his blood glucose was stabilized.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
The reported meter was returned and investigated with retained test strips.The complaint was not confirmed and no new issues were observed.All results were within range specification and no errors were observed during control solution testing and whole blood.In addition, requested product was not received for investigation.Retained test strip samples from the same lot reported by the customer ((b)(4) were tested with control solution instead.All results were within the range specification and no errors were observed.
Event or Problem Description
Customer¿s mother reported customer received a reading from his adc blood glucose meter which was lower than a subsequent reading obtained at the hospital.Caller further reported that on (b)(6) 2017 customer received a reading of ¿lo¿ (a reading less than 20 mg/dl) at 8:00 am and noted he was experiencing ¿fatigue, extreme thirst, was hungry and sleepy¿.Customer then ate breakfast, while caller contacted customer¿s healthcare provider via phone.Caller was instructed to bring the customer to the hospital.At the hospital, a reading of 500 mg/dl was received at 10:30 am from a hospital meter.Customer was hospitalized, diagnosed with hyperglycemia and treated with insulin via intravenous infusion.Customer remained in the hospital for four days while his blood glucose was stabilized.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE PRECISION NEO
• 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: 6341737
• Report Number: 2954323-2017-01258
• Device Sequence Number: 11153903
• Product Code: NBW
• UDI-Device Identifier: 00093815715771
• UDI-Public: (01)00093815715771(17)20180331(10)4500168113
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2017

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: 03/31/2018
• Device Model Number: 71371-75
• Device Lot Number: 4500168113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2017
• Supplement Report FDA Received Date: 04/21/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 14 YR
• Patient Weight: 46