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	Hypoglycemia (1912)
Date of Event	10/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer states that she believes the meter is not working properly because she received a high reading, treated herself, and then started feeling ill and went to the emergency room and received a much lower reading with their meter.The customer stated that within two hours prior to the incident, the customer at a half a sandwich.The customer stated she received a reading of 251.The customer stated she took five units of insulin based on the reading of 251.The customer stated that she then started to feel weird, so she went to the emergency room.At the emergency room, with their blood glucose meter, they tested the customer and received a reading of 41 indicating the customer's blood glucose was low.They gave her graham crackers and apple juice to bring her blood sugar back up.The customer has had her meter for four or more years and stores her meter and strips in the bathroom.Advised customer we don't recommend storing in bathroom or kitchen due to humidity.The customer states she recently had valley fever and is on antibiotics for that.The customer washes and dries hands before testing, uses a new lancet, denies any damage to the meter, and occasionally has trouble getting a blood sample.Based on the incident information provided and that the customer treated herself based on the high reading which she states was incorrect, and incident report was filled out.Replaced meter, strips, sent control solution and return label.
Additional Manufacturer Narrative
As the complaint meter was not returned, i-sens analyzed the accuracy issue with the reference meter and retained strips from the complaint lot.Firstly, as a result of the control solution test, all results satisfied the acceptable range in both a and b levels.Secondly, the tests were conducted with three types of blood with glucose concentrations adjusted to low, medium, and high concentrations.As a result, all readings satisfied 15 mg/dl or % compared to the standard equipment, and sd and cv also satisfied the acceptable range.Therefore, we confirmed that the product is functioning properly.

• 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: 20650222
• Report Number: 3005621222-2024-00012
• Device Sequence Number: 8886049
• Product Code: NBW
• UDI-Device Identifier: 00681131280624
• UDI-Public: (01)00681131280624
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K192220
• 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): 11/11/2024

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: 10/14/2024
• Initial Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Hospitalization
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 91 KG