MAUDE Adverse Event Report: I-SENS, INC. GLUCOCARD SHINE XL BLOOD GLUCOSE TEST SYSTEM; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Model Number	542110
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
Customer did not return meter involved in incident, however, did return the strips involved in the incident.Returned and retain strips of specified lot were tested with qs meter and passed testing with no failures detected.If customer returns the meter involved in the incident, it will be tested and a follow-up mdr will be filed.
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: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): I-SENS, INC.; 43, banpo-daero 28-gil; seocho-gu; seoul, 06646 ; KS 06646
• MDR Report Key: 15595036
• Report Number: 1832816-2022-00022
• Device Sequence Number: 11280727
• 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
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2022
• Report Date (Section F): 10/13/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/13/2024
• Device Model Number: 542110
• Device Catalogue Number: 542110
• Device Lot Number: UF14PAWAD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/17/2022
• Event Location: Home
• Date Report to Manufacturer: 10/13/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/13/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Date Report Sent to FDA: 10/13/2022