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

Model Number	GM505UDF
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the complaint products were not returned, i-sens analyzed the cause of low reading using a meter of the same model and retained strips (ta22bbtwa).As a result of the control solution test, all results were within the standard range, and also the cv% was within the acceptance criteria (below 5%) which was satisfied to internal standard in i-sens.Therefore, it is judged that the product operated normally.
Event or Problem Description
Customer stated her glucose monitor way is way off from her doctor's meter.Her meter read 60, then her doctor's read 416.She said this her second meter she has received, and she's had the meter for about 3-4 months.She said she took a reading on her meter earlier in the day before her doctor's appointment, and it read hi.She took insulin and then she went to her dialysis appointment.When she arrived, they performed a blood test on their meter.Their meter read 416, then about 5 -10 minutes later they performed a blood test using her meter and it read 60.This is an 86% variance and in zone c in parkes grid.She said this happened around 11 am this morning.She stated they did not provide any sort of treatment and there wasn't any medical intervention as there was no adverse event.She's had the meter for about 3-4 months.The meter appears to be in good condition.She's not receiving any oxygen therapy.She washes her hands with soap and water and allows them to dry.She stores both meter and test strips inside a medicine bag that she always carries with her.Customer stated she did not like the variance in results and does not know if her meter is reading correctly and she is worried she's either overdosing or underdosing her insulin, so she would like it replaced.Replaced meter, strips and sent rl.

• 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
• Manufacturer (Section G): I-SENS WONJU FACTORY; 94-1, donghwagongdan-ro; munmak-eup; wonju-si, 26365 ; KS 26365
• Manufacturer Contact: hee seon ; 43, banpo-daero, 28-gil; seocho-gu; seoul, 06646
• MDR Report Key: 13312140
• Report Number: 3005621222-2021-00011
• Device Sequence Number: 4835219
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)00681131169851,(01)00681131169776
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/18/2022

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: 03/21/2023
• Device Model Number: GM505UDF
• Device Catalogue Number: 780001
• Device Lot Number: TA22BBTWA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 52 KG