MAUDE Adverse Event Report: I-SENS, INC. RELION PREMIER CLASSIC BLOOD GLUCOSE TEST SYSTEM; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Model Number	784001 / 780100
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
Investigation activities were completed on october 22, 2024.Customer returned the meter and 9 used/bloody strips of specified lot that were involved in the incident.Since the returned strips could not be used, retain strips of specified lot were tested with returned meter.Blood passed testing.The meter will be offered to the manufacturer for further investigation.
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.Replaced meter, strips, sent control solution and return label.
Additional Manufacturer Narrative
Customer returned meter and strips and the investigation results are pending.Once investigation activities are completed, a follow-up mdr with investigation results will be filed. .

• Brand Name: RELION PREMIER CLASSIC 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: 20487412
• Report Number: 1832816-2024-00014
• Device Sequence Number: 3615105
• Product Code: NBW
• UDI-Device Identifier: 00681131280624
• UDI-Public: (01)00681131280624
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024
• Report Date (Section F): 10/23/2024

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 Expiration Date: 04/04/2026
• Device Model Number: 784001 / 780100
• Device Catalogue Number: 784001 / 780100
• Device Lot Number: XM05BBMZB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/19/2024
• Event Location: Home
• Date Report to Manufacturer: 10/23/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 10/23/2024
• 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: Required Intervention; Life Threatening
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 150 KG
• Date Report Sent to FDA: 10/23/2024