MAUDE Adverse Event Report: I-SENS INC. RELION PREMIER VOICE BLOOD GLUCOSE TEST SYSTEM; BLOOD GLUCOSE MONITORING SYSTEM

Model Number	GM505UBA
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint meter and strips were returned with missing desiccant and cardboard in the bottle, and i-sens performed a specific investigation to analyze the cause of low reading.According to the result of pre-investigation conducted by akray usa, the appearance of complaint test strips did not seem to dispense the enzyme comparing to the normal test strips and i-sens disassembled them to confirm whether the sufficient amount of enzyme had been dispensed.As a result of disassembling the returned strips, it found out that there was traces of enzyme dispensed found but it seemed to be melted by inflow of foreign liquid substance from outside.As we reviewed the device history record of specified lot, it has been confirmed that the enzyme properly dispensed to all row of test strips and they passed vision inspection.Thus, it is assumed that the returned strips were contaminated with foreign liquid substance.
Event or Problem Description
Caller indicated meter was giving low results.Meter is about one month old.He received the control solution and did the test and said the reading was low.Received 63mg/dl.They also have prime meter and he tested his blood and the reading was 371mg/dl.Then tested on the relion premier voice and received a reading of 150mg/dl.

• Brand Name: RELION PREMIER VOICE BLOOD GLUCOSE TEST SYSTEM
• 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: 9177124
• Report Number: 3005621222-2019-00010
• Device Sequence Number: 2775114
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)00681131169851,(01)00681131169776
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K121133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/10/2019

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: 01/02/2021
• Device Model Number: GM505UBA
• Device Catalogue Number: 780001
• Device Lot Number: QD03BBH2C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1