FDA Adverse Event Other Summary report: N

DELTEC COZMO

MDR report key: 746777 · Received September 23, 2005

Report

Report Number
MW1036702
Event Type
Other
Date Received
September 23, 2005
Date of Event
September 22, 2005
Report Date
September 23, 2005
Manufacturer
SMITHS MED MD, INC.
Product Code
LZG
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CT, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAVE USED A DELTEC COZMO INSULIN PUMP, MANUFACTURED BY SMITHS MEDICAL MD, INC., TO CONTROL MY DIABETES FOR JUST ABOUT A YEAR. IN MAY 2005, THE LCD SCREEN INSIDE THE DEVICE CRACKED ITSELF, MAKING THE SCREEN UNREADABLE. AS A RESULT OF THIS, I WAS UNABLE TO TELL HOW MUCH INSULIN I HAD LEFT IN THE DEVICE, OR WHEN I WAS RUNNING LOW, WHEN THE BATTERY WAS DYING, OR WHEN I HAD ALREADY HAD INSULIN ON BOARD SO THAT I COULD LOWER MY INSULIN DOSE. WITHOUT THIS INFO, IT IS QUITE EASY TO GIVE MYSELF TOO MUCH OR TOO LITTLE INSULIN, WHICH, BECAUSE OF THE SENSITIVITY OF MY BODY EASILY RESULTS IN SEVERE HYPO OR HYPERGLYCEMIA, THE LATTER OF WHICH HAS LED TO NUMEROUS HOSPITAIIZATIONS IN MY PAST. AFTER SPEAKING WITH SMITH MEDICAL, I WAS SHIPPED A REPLACEMENT PUMP AT NO CHARGE. HOWEVER, IT REQUIRED EXTENSIVE TRIAL AND ERROR TO RESET MY BASAL RATES AS I COULD NOT READ THE PUMP TO COPY MY DOSAGE DOWN. ON THE NIGHT OF SEP 22, 2005, I EXPERIENCED THE SAME PROBLEM WITH THE REPLACEMENT PUMP THAT I HAD RECEIVED IN MAY. FOR THE SECOND TIME IN LESS THAN ONE YEAR, I HAVE EXPERIENCED THE SAME EXACT PROBLEM WITH THE SAME TYPE OF INSULIN PUMP, THE DELTEC COZMO, MODEL 1700. THE REPRESENTATIVE I SPOKE WITH TOLD ME THAT THEY WOULD SHIP ME A REPLACEMENT DEVICE AGAIN. WHEN I REQUESTED INFO ABOUT HOW I COULD GET A DIFFERENCT MODEL PUMP DUE TO THE REPEATED MALFUNCTION WITH THIS MODEL, I WAS TOLD, "WE CAN SEND YOU A DIFFERENT COLOR PUMP." THIS ASSERTION WAS REPEATED EACH TIME I EXPLAINED TO THE REP WHAT I WAS ASKING FOR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DELTEC COZMO COZMO INSULIN PUMP LZG SMITHS MED MD, INC. 1700 *

Patients

Seq Age Sex Outcome Treatment
1 18 YR Other