FDA Adverse Event Injury Summary report: N

PARADIGM INSULIN PUMP

MDR report key: 5728710 · Received June 13, 2016

Report

Report Number
MW5062881
Event Type
Injury
Date Received
June 13, 2016
Date of Event
June 11, 2016
Report Date
June 13, 2016
Manufacturer
MEDTRONIC
Product Code
LZG
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I AM A TYPE 1 DIABETIC ON A MEDTRONIC PARADIGM INSULIN PUMP. EARLY SATURDAY MORNING, I WOKE UP WITH UNUSUALLY HIGH BLOOD SUGAR, WHICH WAS CONFUSING TO ME. I SOON REALIZED THAT MY INFUSION SET HAD BROKEN IN THE MIDDLE OF THE NIGHT. THE TUBING DISCONNECTED FROM THE HEAD OF THE INFUSION SET WHERE IT GOES INTO MY BODY. ( I HAVE A PICTURE SO YOU CAN SEE WHAT HAPPENED, BUT DO NOT SEE AN ATTACHMENT OPTION). MY PUMP WAS STILL SECURELY IN THE POCKET OF MY SHORTS SO THE TUBING DID NOT BREAK FROM STRAIN OR FROM BEING PULLED BY FALLING OFF THE BED OR ANYTHING. THIS IS THE SECOND TIME THIS HAS HAPPENED TO ME (THE LAST TIME WAS OVER A YEAR AGO IF I HAD TO ESTIMATE). LAST TIME I CONTACTED MY LOCAL MEDTRONIC REP WHO ENDED UP BEING NO HELP AT ALL. I AM EXTREMELY CONCERNED AND UPSET AS THIS SEEMS TO BE A REPEAT ISSUE WITH MEDTRONIC'S INFUSION SETS. HAVING NO INSULIN FOR SEVERAL HOURS IS EXTREMELY DANGEROUS, AND I FELT SICK FROM IT ALL DAY. I AM LUCKY THAT NOTHING WORSE HAPPENED AND THAT I WAS ABLE TO FIX THE ISSUE ALONE. I DON'T WANT ANYONE ELSE TO BECOME UNNECESSARILY ILL, WHICH IS WHY I AM SUBMITTING THIS REPORT. I DID CONTACT MEDTRONIC ON SATURDAY MORNING WAS TOLD THEY WOULD INVESTIGATE IT. IN CASE YOU NEED IT, HERE IS THE INFO ON THE INFUSION SET THAT BROKE: QUICK-SET PARADIGM REF MMT-399, LOT: 5123586, 2018-10, 23 INCH TUBE 6MM NEEDLE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
374933 PARADIGM INSULIN PUMP PARADIGN INSULIN PUMP LZG MEDTRONIC 5123586 2018-10

Patients

Seq Age Sex Outcome Treatment
1 26 YR Disability