MAUDE Adverse Event Report: I-SENS ASSURE PRISM MULTI BLOOD GLUCOSE MONITORING SYSTEM

Model Number	GM505RA
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the complaint products were not returned, i-sens analyzed the accuracy issue with a retained meter and strips from the complaint 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 with blood whose glucose concentration was adjusted to be similar to 621 mg/dl, estimated to be the patient's blood glucose level at the time of the incident.As a result, all readings fall into the acceptance criteria.Therefore, we confirmed that the product is functioning properly.
Event or Problem Description
Caller is reporting that they have had two incidents with this meter, the first one on (b)(6) 2024 and the second one on (b)(6) 2024, where the meter was reading lower than blood readings at the hospital.Meter and strips are always stored on the rig in normal conditions.For the first incident on (b)(6) 2024, caller reported that the ems reading with this meter was 396 at 9:26 am on (b)(6) 2024, the hospital capillary reading was somewhere in the 500's, and the lab test result was about 621.For the second incident on (b)(6) 2024, the reporter did not have specific details on the readings that were received, only that they were lower.Replaced meter, strips, sent control solution and sent return label.
Additional Manufacturer Narrative
As the complaint meter was returned, i-sens analyzed the accuracy issue with the returned meter and strips from the complaint 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 with blood whose glucose concentration was adjusted to be similar to 621 mg/dl, estimated to be the patient's blood glucose level at the time of the incident.As a result, all readings fall into the acceptance criteria.Therefore, we confirmed that the product is functioning properly.
Event or Problem Description
Cvp1av34079.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 1/12/2024 at 12:53 pm and the reading was 359, and she received a reading on tru metrix on 1/12/2024 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: ASSURE PRISM MULTI BLOOD GLUCOSE MONITORING 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: 19122706
• Report Number: 3005621222-2024-00005
• Device Sequence Number: 8230190
• Product Code: NBW
• UDI-Device Identifier: 00015482530501
• UDI-Public: (01)00015482530013,(01)00015482530501
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K151164
• 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 Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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: 06/07/2025
• Device Model Number: GM505RA
• Device Catalogue Number: 530001
• Device Lot Number: WY08MAKMA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2022
• 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; Hospitalization
• Patient Age: 20 YR
• Patient Sex: Female