MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS MINIMED; PUMP, INFUSION, INSULIN

Device Problem Pumping Problem (3016)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Hypoglycemia (1912); Syncope/Fainting (4411)

Event Date 04/25/2021

Event Type  Death  

Event Description

My mother, (b)(6) started having serious swings in her sugars causing her to have extreme lows.The lows would happen at various times of the day.She lived alone which was a challenge, however many times she had the instinctive ability to feel a low coming on.(b)(6) would try to get her levels taken care of before the verge of passing out.I would inevitably get calls several times a week during the night she had a low and fallen trying to get to her sugar tablets.She called her diabetes doctor on many occasions to thinking the pump was not programmed correctly.They would have her come in and program the pump to get her insulin as if the pump was working to its full capabilities.The last low she had was when she was mowing her lawn.She called me telling me she had fallen trying to get inside to get some orange juice to help bring her levels back up.However, she had fallen causing a distal femur fracture.I immediately went and took her to the hospital.She never returned home and passed away months later.I trust all the sugar lows, falls and passing out was directly concurrent to her insulin pump not correctly provided her insulin.Once she was admitted into the hospital, then to the rehabilitation center the pump was removed from her.The doctors at those facilities took her blood on a regular basis and administered her insulin via a syringe.I never was able to find the pump to bring home with her items.I would think her diabetes doctor should have the model information.Fda safety report id# (b)(4).

• Brand Name: MINIMED
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
• MDR Report Key: 15825580
• MDR Text Key: 304007056
• Report Number: MW5113347
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White