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

Model Number 05027250001

Device Problem Inaccurate Delivery (2339)

Patient Problems Hypoglycemia (1912); Coma (2417); Loss of consciousness (2418)

Event Date 02/22/2023

Event Type  Injury  

Manufacturer Narrative

The event occurred outside of the united states.While this product is not sold in the united states, it is like or similar to a product marketed in the united states.

Event Description

It was reported that the infusion device was delivering an inaccurate amount of insulin resulting in hypoglycemia and unconsciousness.The mother administered glucagon and the patient regained consciousness.They then went to see the diabetes doctor.No medical treatment was given.

Manufacturer Narrative

Section d4; catalog number and udi # were corrected based on the returned product.

• Brand Name: ACCU-CHEK ® SPIRIT COMBO
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIABETES CARE GMBH; sandhoferstrasse 116; na; mannheim 68305 ; GM 68305
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 16806571
• MDR Text Key: 313915304
• Report Number: 3011393376-2023-00922
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 04015630880119
• UDI-Public: 04015630880119
• Combination Product (y/n): N
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 05027250001
• Device Catalogue Number: 05027250001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female