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

Model Number	05458544001
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the infusion device shut off without first providing an error or alert message resulting in elevated blood glucose levels.

• 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
• MDR Report Key: 12477605
• Report Number: 3011393376-2021-02865
• Device Sequence Number: 17116582
• Product Code: LZG
• UDI-Device Identifier: 04015630883806
• UDI-Public: 04015630883806
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111353
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2021

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 Model Number: 05458544001
• Device Catalogue Number: 05458544001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 09/17/2021
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 60