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

Model Number	GM01XBB
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the complaint meter was not returned, i-sens analyzed the accuracy issue with a reference meter and retained strips from the same lot.Firstly, as a result of the control solution test, all results satisfied the acceptable range in both a and b levels.Secondly, we conducted the clinical test and all 30 data satisfied the accuracy standard of iso 15197:2013.Therefore, we confirmed that the product is functioning properly.
Event or Problem Description
F069321k6470.Lot ul12bbehe - 2024-08-11 - 100ct.The patient is receiving high readings.The patient has had meter for about three months and has just recently had an issue with it.The patient was taken to the hospital because of the readings, and they did a blood draw.The patient has not done a control solution test and walmart did not offer control solution and caller was not aware.The caller is contacting us on behalf of the patient.The patient keeps strips in the original bottle.The patient keeps meter and test strips in bedroom away from humidity and direct sunlight.The last five readings are 301, 427 at 6 am, 245 last night, 354 during day yesterday, and 422 yesterday sometime.This meter does not record the date and times of the exact readings, so i was not able to get them.The patient is not on oxygen therapy.The patient keeps strips in the original bottle and the lid closed at all times.The patient has no difficulty getting a blood sample.The patient changes lancets everyday but not always before each test.The patient tests on fingertips only and uses an alcohol wipe before each test.The patient uses the second drop of blood.Today the reading was in the 400's and they were concerned about it, so the caller took the patient to the hospital, and they took his blood and said that his sugar was not in the 400's.The patient was not experiencing any symptoms at the time.The hospital used a fingerstick and it was around 180 and then did a blood draw later and came back around 180.About 30 minutes had passed between relion compact meter reading and hospital reading.The patient only does insulin usually once per week but did take metformin based off the reading this morning of 427 and then went to the hospital.Replaced meter, strips, sent control solution and return label.

• Brand Name: RELION PREMIER COMPACT 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: 18754862
• Report Number: 3005621222-2024-00002
• Device Sequence Number: 11688192
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)30681131240728,(01)00681131169776
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120759
• 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): 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/11/2024
• Device Model Number: GM01XBB
• Device Catalogue Number: 783110
• Device Lot Number: UL12BBEHE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 113 KG