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

Model Number	GM505RA
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	12/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
They have been having issues with these glucometers.They have had three occurrences in the past few weeks where the readings have been off.Reporter was on one call where the patient's free style libre read 55 and the prism read 98.They re-checked after they started an iv and the prism read 102.After arrival to the hospital, they checked again, and it was now 33 on another meter.They swapped to a different monitor on that ambulance.
Additional Manufacturer Narrative
As the complaint meter was not returned, i-sens analyzed the high reading issue with a retained meter and strips from the same lot.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.
Additional Manufacturer Narrative
As the complaint meter was returned, i-sens analyzed the accuracy issue using the returned 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.Even when the meter was disassembled, there were no abnormalities such as inflow of blood/foreign substance into the connector or damaged pins.Therefore, it is judged that the product operated normally.

• Brand Name: ASSURE PRISM 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: 16348906
• Report Number: 3005621222-2023-00002
• Device Sequence Number: 6260563
• Product Code: NBW
• UDI-Device Identifier: 00015482530501
• UDI-Public: (01)00015482530013,(01)00015482530501
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K083468
• 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): 03/08/2023

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: Health Professional
• Device Expiration Date: 04/04/2024
• Device Model Number: GM505RA
• Device Catalogue Number: 530001
• Device Lot Number: UM05MAA2A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Female