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

Model Number	GM505RA
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the complaint meter was not returned, i-sens analyzed the accuracy 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.
Event or Problem Description
Customer has been having issues with these glucometers.They stated they have had three occurrences in the past few weeks where the readings have been off.They received a call for patient experiencing diabetic problems.He had fallen.He was alert but confused.The patient's son had given honey before the ambulance arrived.They checked the patient's sugar.They received a reading of 155.The paramedics gave him glucose gel, food (sandwich) and juice.They checked him again and the meter read 90, which they feel was incorrect and should have been higher after the honey, the glucose gel, so they think the meter read too high when he was originally tested, and he was low.The patient became alert, and he was able to answer all their questions.He came back to normal.He was not transported to the hospital.Verified they change the lancets each time they test.They use alcohol to clean fingers and allow finger to dry completely.Patient was not receiving any oxygen therapy.Patient doesn't have trouble getting a blood sample.The meter and test strips are stored together in the back of the ambulance in a temperature-controlled environment.Replaced meter, strips and sent return label.
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: 16344008
• Report Number: 3005621222-2023-00001
• Device Sequence Number: 6918647
• 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): 03/03/2023

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: 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): Initial
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2022
• 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 Age: 51 YR
• Patient Sex: Male
• Patient Weight: 77 KG