MAUDE Adverse Event Report: I-SENS INC. CARESENS N BLOOD GLUCOSE MONITORING; BLOOD GLUCOSE MONITORING SYSTEM

Model Number	GM505NA
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the customer had thrown away the complaint device and only given lot information of strip, i-sens analyzed the cause of higher readings than expectation with normal meter and retained strips.As a result of control solution test, all the measured values were within standard range, and the cv% was within the acceptance criteria (below 5%) which was satisfied to the standard at i-sens.As stated in the description of event, the fruit on the customer' finger might have contaminated blood sample, resulting in an erroneous reading.
Event or Problem Description
The customer checked his blood glucose after eating a fruit and coffee between 3 and 4 p.M., and it was 87mg/dl.However, he had symptoms of low blood glucose.They called the paramedics, they came in and checked his blood glucose about 15 minutes later, and it was 37mg/dl.The paramedics gave him an iv, was taken to the hospital.They kept him there for 3 hours, until his blood glucose was 260mg/dl.

• Brand Name: CARESENS N BLOOD GLUCOSE MONITORING
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): I-SENS INC.; 43, banpo-daero, 28-gil; seocho-gu; seoul, 06646 ; KS 06646
• MDR Report Key: 8287759
• Report Number: 3005621222-2019-00001
• Device Sequence Number: 2418626
• Product Code: NBW
• UDI-Device Identifier: 00885325000023
• UDI-Public: (01)00885325000023
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K083468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/04/2020
• Device Model Number: GM505NA
• Device Catalogue Number: 164301-202
• Device Lot Number: QU05LR02N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1