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

Model Number	GM505UCE
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
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, the test was conducted using three levels of capillary blood.The sd of the results were below 5% and met the internal acceptance criteria, and all deviations were within 15mg/dl or % compared to the reference equipment.Therefore, we confirmed that the product is functioning properly.
Event or Problem Description
(b)(6).Lot wl11bbaja - 2025-08-01 - (b)(4).Caller has a dexcom, and the classic meter is reading high compared to the dexcom and her tru metrix meter that she has.Caller received a reading on classic on (b)(6) 2024 at 12:53 pm and the reading was 359, and she received a reading on tru metrix on (b)(6) 2024 at 12:55 pm and it was 71.Customer did not report any adverse event issues from these readings.Caller did not give any result examples from the dexcom.The compared readings of 359 and 71 are outside zones a & b and this would be considered a malfunction and reportable.Replaced meter, strips, sent control solution and sent return label.
Additional Manufacturer Narrative
Before the complaint products were returned, i-sens analyzed the reading issue using a reference meter and retained strips from the same lot.As a result of the control solution test, all results were within the standard range, and the cv% satisfied the internal standard in i-sens (below 5%).Subsequently, after the complaint meter was returned, the test was conducted with the returned meter and the blood whose glucose concentration was adjusted to be similar to 71 mg/dl, estimated to be the patient's blood glucose level at the time of the incident.The sd of the results was 5% and met the internal acceptance criteria, and all deviations were within 15mg/dl compared to the reference equipment.Therefore, we confirmed that the product is functioning properly.
Event or Problem Description
(b)(6).Lot wl11bbaja - 2025-08-01 - 100ct.Caller has a dexcom, and the classic meter is reading high compared to the dexcom and her tru metrix meter that she has.Caller received a reading on classic on (b)(6) 2024 at 12:53 pm and the reading was 359, and she received a reading on tru metrix on (b)(6) 2024 at 12:55 pm and it was 71.Customer did not report any adverse event issues from these readings.Caller did not give any result examples from the dexcom.The compared readings of 359 and 71 are outside zones a & b and this would be considered a malfunction and reportable.Replaced meter, strips, sent control solution and sent return label.

• Brand Name: RELION PREMIER CLASSIC 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: 18700731
• Report Number: 3005621222-2024-00001
• Device Sequence Number: 6155930
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)00681131280624,(01)00681131169776
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K192220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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: 08/01/2025
• Device Model Number: GM505UCE
• Device Catalogue Number: 784001
• Device Lot Number: WL11BBAJA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2024
• Supplement Date Received by Manufacturer: 02/17/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2022
• 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
• Patient Sex: Female