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

Device Problem Inaccurate Delivery (2339)

Patient Problems Fainting (1847); Hypoglycemia (1912)

Event Date 12/10/2020

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.Case with patient identifier (b)(6) is related to case with patient identifier (b)(6).Product is not expected to be returned.

Event Description

It was reported that the infusion device was delivering an inaccurate amount of insulin, which led to fainting during a shower.At 5:30 pm the patient had a low blood glucose reading and his sister placed some sugar under the patient's tongue and called the paramedics.He was transported to hospital at approximately 6:00 pm.Treatment at the hospital is unknown, but the patient was taken for an x-ray because he fell down when he fainted.The stay at the hospital is unknown.

• 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 DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim 68305 ; GM 68305
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 11064492
• MDR Text Key: 223371992
• Report Number: 3011393376-2020-04624
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Device Age: NULL
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR