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

Model Number	541100
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Caller was not able to find lot number.We did a cs test and the meter read below the range.They just opened cs today.Replaced meter, strips, cs and sent rl.
Additional Manufacturer Narrative
I-sens retrieved the complaint meter and strips and analyzed the cause of the incorrect reading.The result of the control solution test was 97mg/dl(h: 203~274mg/dl) which was lower than the acceptable range.As a result of conducting a detailed analysis to determine the cause, it was confirmed that the meter counter pin was deformed.As reviewing in-process inspection record and qc data of complaint meter, it has been confirmed that the returned meter properly displayed measured value (approximately glucose concentration of 200mg/dl) and passed qc inspection.Also, there were 281 data saved in the meter, so it is presumed that a problem occurred due to improper use such as inserting the test strip upside down into the connector or inserting an object other than the test strip.

• Brand Name: GLUCOCARD SHINE 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: 12974284
• Report Number: 3005621222-2021-00010
• Device Sequence Number: 17305053
• Product Code: NBW
• UDI-Device Identifier: 00015482540012
• UDI-Public: (01)00015482540012
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120351
• 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): 12/10/2021

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: 10/01/2022
• Device Model Number: 541100
• Device Catalogue Number: 541100
• Device Lot Number: SS02PATDB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2021
• Initial Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2020
• 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 Sex: Unknown