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

Model Number	GM505UDF
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the complaint meter was not returned, i-sens analyzed the precision issue with a reference meter and retained strips.As a result of the control solution test, all results were within the standard range, and the cv% was within the acceptance criteria (below 5%), which satisfied the internal standard in i-sens.Therefore, it is judged that the product operated normally.
Event or Problem Description
Serial number is rubbed off.Caller stated meter is "acting up" and she's scared the meter is not working correctly.Caller stated first the meter read low, like "50something", and caller stated she also doublechecks whenever she has a low or a high reading.So, she did another test and received a reading of "hi" on the screen.She waited 15 minutes and tested again and received a reading of 127.Caller stated the readings of "50something", and "hi" were within 10 minutes.Caller stated she used a fresh blood sample for each reading.Caller stated she tries to use a new lancet before each test.Caller cleanses hands with soap and water.Caller then stated that this meter is used on her daughter.Daughter is not on oxygen therapy.Test strips were opened about a week ago.Caller stated the test strip bottle is closed immediately after removing a strip.Test strips and meter are stored together in the pouch, and they are always with the caller.Extra test strips are stored in a kitchen cabinet.Caller stated although she cannot find her control solution right now, the last time she tested, it tested within range.Caller stated her daughter is 12 years old.Caller stated that her daughter did not have anything to eat, nor any medications prior to testing.Caller stated it was just regular test, and stated she tests throughout the day, not just at mealtimes, but when she tested her, she was not showing any symptoms of either low or high readings.Caller stated the daughter was not treated based on the readings and there was no adverse event that required medical attention and that she didn't trust the readings and then used an auxiliary backup meter, and she received normal readings.Replaced meter, strips and sent return label.

• Brand Name: RELION PREMIER VOICE BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): I-SENS; 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: hyojin baik ; 43, banpo-daero 28-gil; seocho-gu; seoul, 06646 ; KS 06646
• MDR Report Key: 15424985
• Report Number: 3005621222-2022-00015
• Device Sequence Number: 7502083
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)00681131169851,(01)00681131169776
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/13/2022

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: 11/18/2023
• Device Model Number: GM505UDF
• Device Catalogue Number: 780001
• Device Lot Number: TB19BBE4A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 12 YR
• Patient Sex: Unknown