MAUDE Adverse Event Report: I-SENS INC. CARESENS N BLOOD GLUCOSE MONITORING SYSTEM; BLOOD GLUCOSE TEST 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	07/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As soon as the device was retrieved, analysis was performed by i-sens with returned device and retained strips.The measurement precision was evaluated using control solution and all the measured values were within the standard range.The cv% was within the acceptance criteria (below 5%) which was satisfied with the standard at i-sens as well confirming that the device was performing as intended.Thus, it is believed that the meter properly functioned.
Event or Problem Description
The patient took a fasting blood glucose test in the morning as usual, and the first result was 'hi'.Directly after took a test and the result was 506 mg/dl.It was still much higher than expected (expects between 190 mg/dl and 240 mg/dl) so she called an ambulance.No treatment was performed on her between the reading taken at home and the ambulance arriving 15 mins later.She had no symptoms consistent with the high readings.When the emts tested her with their bgm (unknown brand), the result was 211 mg/dl which is on par with her usual readings at that time.They treated her with insulin and she remained at home.She is type 2 insulin dependent diabetic.She has no other way to check her blood sugar currently.She will return her meter.

• Brand Name: CARESENS N BLOOD GLUCOSE MONITORING SYSTEM
• Common Device Name: BLOOD GLUCOSE TEST SYSTEM
• Manufacturer (Section D): I-SENS INC.; 43, banpo-daero, 28-gil; seocho-gu; seoul, 06646 ; KS 06646
• MDR Report Key: 6783883
• Report Number: 3005621222-2017-00004
• Device Sequence Number: 1566431
• Product Code: NBW
• UDI-Device Identifier: 00885325000115
• UDI-Public: 00885325000115
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Service Personnel
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/03/2017

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: 09/29/2018
• Device Model Number: GM505NA
• Device Catalogue Number: 164301-202
• Device Lot Number: NT30LX88K(STRIP)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 08/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR