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

Model Number	05391512001
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the infusion device was delivering an inaccurate amount of insulin 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: 10209012
• Report Number: 3011393376-2020-02261
• Device Sequence Number: 3623495
• Product Code: LZG
• UDI-Device Identifier: 04015630883479
• UDI-Public: 04015630883479
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 09/08/2020

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: 05391512001
• Device Catalogue Number: 05027250001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 09/08/2020
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 53