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

Model Number	GM505RA
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Meter is reading lo with blood and cs.Batteries were changed.Meter was brought on a call.The reason for the call was not a diabetic related issue.Patient was not exhibiting any diabetic symptoms.The paramedics performed a blood glucose test on the patient because that is a standard thing they do on all calls.Patient was not undergoing oxygen therapy.Patient's finger was cleansed using an alcohol swab.Patient's fingertip was lanced for blood sample.There was no trouble getting a blood sample during the call.Caller described their testing procedure which is the correct way to apply blood to the test strip.Patient was not having any blood glucose related symptoms.Blood glucose was tested, and the meter read lo.User was unsure if that was correct, and they always have two meters on hand, so they used their other meter to check blood glucose and received a normal reading.No treatment was provided based on the lo reading, and no treatment was provided based on any reading they received during that call.Customer stated they also performed several cs tests on the meter, and it is only reading lo.Meter and test strips are stored together in a climate-controlled environment.Meter and strips have not been exposed to extreme temperatures or humidity.
Additional Manufacturer Narrative
As the complaint products were not returned, i-sens analyzed the cause of low reading using a retained meter and strips.As a result of the control solution test, all results were within the standard range.In addition, 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
Meter is reading lo with blood and cs.Batteries were changed.Meter was brought on a call.The reason for the call was not a diabetic related issue.Patient was not exhibiting any diabetic symptoms.The paramedics performed a blood glucose test on the patient because that is a standard thing they do on all calls.Patient was not undergoing oxygen therapy.Patient's finger was cleansed using an alcohol swab.Patient's fingertip was lanced for blood sample.There was no trouble getting a blood sample during the call.Caller described their testing procedure which is the correct way to apply blood to the test strip.Patient was not having any blood glucose related symptoms.Blood glucose was tested, and the meter read lo.User was unsure if that was correct, and they always have two meters on hand, so they used their other meter to check blood glucose and received a normal reading.No treatment was provided based on the lo reading, and no treatment was provided based on any reading they received during that call.Customer stated they also performed several cs tests on the meter, and it is only reading lo.Meter and test strips are stored together in a climate-controlled environment.Meter and strips have not been exposed to extreme temperatures or humidity.
Additional Manufacturer Narrative
As the complaint product was returned, i-sens analyzed the cause of incorrect reading using the returned meter and strips.As a result of the control solution test, all results were within the standard range, and also the cv% was within the acceptance criteria (below 5%), which was satisfied to internal standard in i-sens.However, as a result of disassembling the meter, it was confirmed that foreign substances had flowed into the connector.Since 500 data are stored, it is assumed that intermittent incorrect readings may have occurred due to foreign substances flowing in during use.

• Brand Name: ASSURE PRISM MULTI BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): I-SENS, INC.; 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: hee seon ; 43, banpo-daero, 28-gil; seocho-gu; seoul, 06646
• MDR Report Key: 14903269
• Report Number: 3005621222-2022-00003
• Device Sequence Number: 20382620
• Product Code: NBW
• UDI-Device Identifier: 00015482530501
• UDI-Public: (01)00015482530013,(01)00015482530501
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/08/2022

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: 07/29/2023
• Device Model Number: GM505RA
• Device Catalogue Number: 530001
• Device Lot Number: TU30MAU9A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 07/04/2022
• Supplement Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2019
• 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