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

Model Number	05458544001
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient's doctor reported the patient was hospitalized on (b)(6) 2021 with diabetic ketoacidosis and high blood glucose of 413 mg/dl.The patient had not been using the infusion device for an undetermined amount of time due to an unknown error message.He was initially treated with an iv of novolog and is now using insulin injections.The infusion device could not be returned because the doctor was unable to provide additional patient information and the patient was unavailable at the time of the report.
Additional Manufacturer Narrative
No product will be returned for evaluation.

• 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 DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim 68305 ; GM 68305
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 12960206
• Report Number: 3011393376-2021-03793
• Device Sequence Number: 5424562
• Product Code: LZG
• UDI-Device Identifier: 04015630883806
• UDI-Public: 04015630883806
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111353
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2021

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 Model Number: 05458544001
• Device Catalogue Number: 05458544001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMDELOG INSULIN
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 32 YR
• Patient Sex: Male