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

Model Number	GM505RA
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer stated meter k008006k1319 gave a reading of 450, but when they got to the hospital the reading was 1,300.Customer was unable to provide strip lot information as they no longer had the strips that were used during the incident.Customer also reported that they performed a control solution test when they returned and the control solution test did pass testing within range, but they were not able to provide the control solution lot number.During the second call on (b)(6) 2023, the caller indicated that meter k008006k1319 had the value of 297 and upon meter return, that value was found in the recent meter memory.On (b)(6) 2023 and (b)(6) 2023 product complaint analyst attempted to contact the caller for follow-up to gather and confirm more information about these meters, but was unable speak with the customer, but did leave a voicemail requesting the caller to give us a call back to provide more information.Product complaint analyst did finally speak to the caller today ((b)(6) 2023).Customer confirmed that the reading of 297 was on meter k008006k1319, and the value of 450 was received on meter k008119h2326.The reason she said she didn't send k008119h2326 back is because she was waiting, and still is waiting, for more information regarding that meter from the paramedic that was on that call, but she has received nothing from him after repeated attempts of trying.Customer stated she would return meter k008119h2326 as soon as possible.Replaced meter and sent return label.
Additional Manufacturer Narrative
As the complaint meter was returned, i-sens conducted control solution and blood tests using the complaint meter and reference strips.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 capillary blood with a concentration similar to the customer's blood glucose level at the time of the issue, and it resulted in "hi" (occurring when the glucose level is above 600mg/dl) for all 10 tests.Therefore, it is confirmed that the meter is operating normally.The following is a partial excerpt from the assure prism multi user manual, regarding its limitations: "inaccurate results may occur in severely hypotensive (having low blood pressure) individuals or patients in shock.Inaccurate low results may occur for individuals experiencing a hyperglycemic hyperosmolar state, with or without ketosis.Critically ill patients should not be tested with the assure?? prism multi blood glucose monitoring system." based on the reported customer's blood glucose level, it is inferred that the customer may be experiencing a hyperglycemic hyperosmolar state.In such cases, assure prism may produce inaccurate measurement values as stated in the user manual.

• 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: 17057785
• Report Number: 3005621222-2023-00007
• Device Sequence Number: 15186352
• Product Code: NBW
• UDI-Device Identifier: 00015482530013
• UDI-Public: (01)00015482530013
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/05/2023

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 Model Number: GM505RA
• Device Catalogue Number: 530001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2019
• 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: Hospitalization; Other
• Patient Sex: Unknown