MAUDE Adverse Event Report: MEDTRONIC MINIMED GUARDIAN REAL-TIME MONITIOR; CGM

Model Number CSS7100NA

Device Problem Inaccurate Delivery (2339)

Patient Problems Stroke/CVA (1770); Death (1802); Encephalopathy (1833); Sepsis (2067); Electrolyte Imbalance (2196); Diabetic Ketoacidosis (2364); Coma (2417)

Event Date 09/23/2013

Event Type  Death  

Event Description

It was reported that the customer was deceased due to an event unrelated to insulin delivery.The blood glucose reading was unknown.The customer's daughter stated that she had a stroke, an infection, and her blood glucose levels were going down.The customer could not feel her right side, went into a coma and then died.She was wearing the insulin pump at the time of hospitalization and removed it upon admittance into the emergency room.The customer was reported to have had cardiorespiratory sepsis, acute encephalopathy, diabetic ketoacidosis, hypernatremia, possible "myocanoine" type of infection, and possible pneumonia.She stated that she had a biopsy and it came back negative.Requested the device to be returned for analysis.Nothing further reported.

Manufacturer Narrative

The insulin pump was received without the original battery.The unit passed all functional testing, including an error test and self test.The device communicated properly to the glucose sensor simulator.No lost sensor alarm was noted.The device was received with cracked battery tube threads and minor scratched display window.

• Brand Name: GUARDIAN REAL-TIME MONITIOR
• Type of Device: CGM
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325 121
• Manufacturer Contact: christopher tupper ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764313
• MDR Report Key: 4079409
• MDR Text Key: 4896694
• Report Number: 2032227-2014-20998
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P980022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/10/2014

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
• Device Operator: Lay User/Patient
• Device Model Number: CSS7100NA
• Device Catalogue Number: CSS7100NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/19/2014
• Initial Date FDA Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Weight: 50