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

Model Number	05458544001
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product is not expected to be returned for evaluation.
Event or Problem Description
It was reported that the infusion device was delivering an inaccurate amount of insulin resulting in hyperglycemia.The customer reported that high blood glucose symptoms of dehydration, lightheadedness, vomiting, and chills started on (b)(6) 2020.The customer attempted to self treat her blood glucose for several days by administering correction boluses and insulin injections.On (b)(6) 2020 at 7:30am the customer received a blood glucose result of 360 mg/dl on her fora brand meter.The customer had her husband take her to the emergency room at 10:30am on (b)(6) 2020.The customer's blood glucose was taken upon arrival at the hospital, however the result was unknown.The patient was diagnosed with diabetic ketoacidosis and was treated with an insulin iv and other iv fluids.The customer was discharged from the hospital on (b)(6) 2020 at 10:30am with a blood glucose result of 98 mg/dl.

• 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: 10422747
• Report Number: 3011393376-2020-02975
• Device Sequence Number: 2757778
• Product Code: LZG
• UDI-Device Identifier: 04015630883806
• UDI-Public: 04015630883806
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 08/18/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 05458544001
• Device Catalogue Number: 05458544001
• Was Device Available for Evaluation?: No
• Device Age: NULL
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 08/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 71