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

Model Number	05391512001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Hyperglycemia (1905); Vomiting (2144)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was in the hospital due to hyperglycemia with a blood glucose value of hi mg/dl (> 600 mg/dl).The patient and the patient's nurse stated that the pump triggered error message e10 (=cartridge error), which was unclearable.The user was treated with insulin intravenously.At the time of the call, the patient was still in the hospital and it was uncertain when she would be discharged.

• 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: 11959404
• Report Number: 3011393376-2021-01755
• Device Sequence Number: 19162965
• Product Code: LZG
• UDI-Device Identifier: 04015630883479
• UDI-Public: 04015630883479
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 10/05/2021

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: 05391512001
• Device Catalogue Number: 05027250001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 06/09/2021; 10/04/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 06/10/2021; 10/05/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOVOLOG INSULIN; NOVOLOG INSULIN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 62