MAUDE Adverse Event Report: I-SENS GLUCOCARD SHINE XL BLOOD GLUCOSE TEST SYSTEM; BLOOD GLUCOSE MONITORING SYSTEM

Model Number	GM505NA
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Hypoglycemia (1912); Dizziness (2194)
Date of Event	09/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the complaint products were not returned, i-sens analyzed the cause of the high readings using a meter of the retained meter and strips of 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
The customer purchased a shine xl meter on (b)(6) 2022.The customer began using the new meter on (b)(6) 2022.Prior to purchasing the shine xl meter, the customer used a contour next meter.The readings the customer receives on the shine xl meter are much higher than the readings that he received on his old meter.The customer stated that he received readings of 479 and 411 on the shine xl meter.The customer had been fasting prior to testing.The customer claims that this is causing him to take more units of insulin than needed.The customer has not actually been hospitalized due to this, but he has been in communication with his doctor by phone.His doctor has advised him to go to the er due to the high readings.The customer states he was not able to go to the er due to a lack of transportation and he did not feel safe to drive on his own due to feeling drowsy and lightheaded.I performed three blood tests with the customer, and he received readings of 164, 167, and 151.He states that he should receive readings around 98-100.Customer does not trust the meter and would like it replaced.Replaced meter, strips, sent control solution and return label.

• Brand Name: GLUCOCARD SHINE XL 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: 15603156
• Report Number: 3005621222-2022-00017
• Device Sequence Number: 2315110
• Product Code: NBW
• UDI-Device Identifier: 00015482540500
• UDI-Public: (01)00015482542108,(01)00015482540500
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/14/2022

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: 03/13/2024
• Device Model Number: GM505NA
• Device Catalogue Number: 542110
• Device Lot Number: UF14PAWAD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2022
• 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
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 75 KG