MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. RELION PLATINUM; BLOOD GLUCOSE MONITORING TEST STRIPS

Catalog Number	09409963001
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient received the following results within 15 minutes: 156 mg/dl with the relion system and 87 mg/dl with a professional meter.

• Brand Name: RELION PLATINUM
• Common Device Name: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIABETES CARE, INC.; 9115 hague road; na; indianapolis IN 46250 1025
• Manufacturer Contact: natalie catton ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 23001722
• Report Number: 3011393376-2025-00921
• Device Sequence Number: 9413499
• Product Code: NBW
• UDI-Device Identifier: 00681131403283
• UDI-Public: 00681131403283
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K203711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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 Catalogue Number: 09409963001
• Device Lot Number: 303784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/03/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 148 KG