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	06/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint meter and strips were returned with broken strip bottle cap, and i-sens performed a specific investigation to analyze the cause of inaccurate reading.According to the result of pre-investigation conducted by (b)(4), the returned strips were disassembled to check 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 but it seemed to be melted by inflow of foreign liquid substance from outside.As we reviewed the device history record of complaint lot, it has been confirmed that the enzyme was properly dispensed to all row of test strips and they passed vision inspection.Thus, it is assumed that the customer accidentally dropped the test strips when he/she twisted and opened the strip bottle cap so the test strips were contaminated by foreign liquid substance since the returned strip bottle cap had a broken hinge.
Event or Problem Description
Caller indicated the relion premier voice meter was giving variable readings.He has only had the meter since the beginning of june, and has only used three times.He said that he was getting inaccurate readings.He said that he was getting different readings when he was doing his tests at home.Customer refused to do any troubleshooting.Customer wants a different meter.Advised to try the premier blu meter.Sent return label to customer to send products back for testing.

• 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: 9132504
• Report Number: 3005621222-2019-00009
• Device Sequence Number: 19594691
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)00681131169851,(01)00681131169776
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/27/2019

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: 12/07/2020
• Device Model Number: GM505UBA
• Device Catalogue Number: 780001
• Device Lot Number: QN08BBE5C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2019
• Initial Report FDA Received Date: 09/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1