MAUDE Adverse Event Report: MEDTRONIC MINIMED MINILINK TRANSMITTER MMT-7703NA; SENSOR, GLUCOSE, INVASIVE

Model Number MMT-7703NA

Device Problems Break (1069); Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hyperglycemia (1905); Unspecified Infection (1930); Diabetic Ketoacidosis (2364); Coma (2417)

Event Date 04/23/2018

Event Type  Death  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

It was reported that the customer passed away in hospital.The customer was hospitalized on (b)(6) 2018 due to high blood glucose, diabetic ketoacidosis, and a coma.The cause of death was a coma and diabetic ketoacidosis.The caller stated that the customer had no illnesses that may have led to the customer's passing.The customers blood glucose was over 1500 mg/dl at the time of admission.The customer was not wearing the insulin pump at the time of death.The pump had been removed within less than 48 hours prior to passing, as the paramedics took off the pump.The customer was using sensors.The caller also reported that the customer had a high of over 600 on (b)(6) 2018 and they woke up vomiting, and later that day they noticed that the tubing that came out was broken and really loose like it had been cut.The caller declined to return the insulin pump for analysis or to upload the pump.

Manufacturer Narrative

The event was reported in error.

Manufacturer Narrative

The initial report was created in error as it was previously reported under mdr number 3004209178-2018-77974.

• Brand Name: MINILINK TRANSMITTER MMT-7703NA
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219
• MDR Report Key: 7584958
• MDR Text Key: 110569824
• Report Number: 2032227-2018-04849
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7703NA
• Device Catalogue Number: MMT-7703NA
• Device Lot Number: A000330545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 42 YR
• Patient Weight: 200