MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® SPIRIT COMBO; INSULIN INFUSION PUMP

Catalog Number	05027250001
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred outside of the united states.While this product is not sold in the united states, it is like or similar to a product marketed in the united states.
Event or Problem Description
It was reported that the infusion device was delivering an inaccurate amount of insulin.This resulted in low blood glucose values of 48 mg/dl and one day later in elevated blood glucose levels of 250 mg/dl.
Additional Manufacturer Narrative
Correction: in d4 the catalog no and unique identifier information was updated based on the returned product.

• Brand Name: ACCU-CHEK ® SPIRIT COMBO
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIABETES CARE GMBH; sandhoferstrasse 116; na; mannheim 68305 ; GM 68305
• Manufacturer Contact: brian frazier ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 21444814
• Report Number: 3011393376-2025-00369
• Device Sequence Number: 17941104
• Product Code: LZG
• UDI-Device Identifier: 04015630880119
• UDI-Public: 04015630880119
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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: 05027250001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN INSULIN
• Patient Age: 84 YR
• Patient Sex: Male