MAUDE Adverse Event Report: I-SENS RELION¿ PREMIER CLASSIC METER; PORTABLE BLOOD GLUCOSE METER

Model Number	784001
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the complaint items were not returned, i-sens proceeded with a root cause analysis using a reference meter and retained strips from the complaint lot.First, as a result of the control solution test, all readings in both a and b levels met the acceptable range.Second, when tested with blood prepared at approximately 147 mg/dl, which is assumed to be the patient's blood glucose level at the time of the incident, all results met the acceptable criteria.Therefore, it was confirmed that the product is functioning normally.
Event or Problem Description
The customer is calling on behalf of her husband.She stated he is receiving inaccurate readings.She stated she called the paramedics two weeks ago when reading on the meter was 381.Customer purchased meter two weeks ago.The patient's wife stated she was concerned with his reading and called the paramedics since the reading on classic meter was 381 when she took it at 7:30 am.When the paramedics arrived, he did not have to take any insulin due to the reading received on their meter being 147.The paramedics recommended for meter to be calibrated.No treatment was provided by the paramedics, they tested the patient and left.

• Brand Name: RELION¿ PREMIER CLASSIC METER
• Common Device Name: PORTABLE BLOOD GLUCOSE METER
• 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: 20490543
• Report Number: 3005621222-2024-00011
• Device Sequence Number: 11805711
• Product Code: NBW
• UDI-Device Identifier: 00681131280624
• UDI-Public: (01)00681131280624
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K121133
• 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): 10/21/2024

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 Model Number: 784001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2023
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 68 KG