MAUDE Adverse Event Report: I-SENS RELION PREMIER CLASSIC BLOOD GLUCOSE TEST SYSTEM; BLOOD GLUCOSE MONITORING SYSTEM

Model Number	N/A
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Headache (1880); Hypoglycemia (1912); Vomiting (2144); Chills (2191); Diaphoresis (2452)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has not been returned from the customer, and the serial number of the meter received via phone call is presumed to be incorrect as there is no production history associated with it.Therefore, based on the product name reported by the customer, i-sens analyzed the accuracy issue with a reference meter and retained strips from the same lot.As a result of the control solution test, all results were within the standard range, and the cv% was within the acceptance criteria (b)(4), which satisfied the internal standard in i-sens.Therefore, it is judged that the product operated normally.
Event or Problem Description
Caller stated that meter had been giving incorrect readings and noted that the readings appeared to be of a normal level, so the patient continued with his normal routine.On the day of the incident, the patient was exhibiting symptoms of low blood sugar, so 911 was called.Because he was low, he ate some sweet foods before the paramedics arrived to get his blood sugar back up.The paramedics checked his levels with a blood glucose test, and they received a reading of 79 with their meter, but the classic meter read 115.Checked glucose readings again in the ambulance and they gave him a glucose drink to get his blood glucose level back up.The ambulance took him to the hospital for further treatment.They did lab work at the hospital.He ended up vomiting at the hospital and received further treatment until he was stable enough to go home.Replaced meter, strips, sent control solution and return label.

• Brand Name: RELION PREMIER CLASSIC BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• 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: 17263045
• Report Number: 3005621222-2023-00010
• Device Sequence Number: 20323448
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)00681131280624,(01)00681131169776
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/05/2023

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: 12/27/2024
• Device Model Number: N/A
• Device Catalogue Number: 784001
• Device Lot Number: UN28BBRHF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 136 KG