FDA Adverse Event Injury Summary report: N

INNOVO

MDR report key: 430769 · Received December 4, 2002

Report

Report Number
9681821-2002-00059
Event Type
Injury
Date Received
December 4, 2002
Date of Event
September 1, 2002
Report Date
November 8, 2002
Manufacturer
NOVO NORDISK A/S, MEDICAL SYSTEMS
Product Code
FMF
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

ELEVATED BLOOD GLUCOSE LEVELS AND DKA [DIABETIC KETOACIDOSIS] [BLOOD GLUCOSE INCREASED]. A PT WHO WAS INTRODUCED TO AN INNOVA INSULIN DOSER WITH NOVOLOG PENFILL (INSULIN ASPART) IN JULY 2002 FOR TYPE 1 DIABETES, EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS AND WAS HOSPITALIZED WITH DIABETIC KETOACIDOSIS IN 2002. THE PT STATED THAT THEY BELIEVE THE DEVICE IN QUESTION WAS NOT DELIVERING THE CORRECT AMOUNT OF INSULIN. THE INNOVO WORKED WELL AND THEIR BLOOD GLUCOSE LEVELS WERE WELL CONTROLLED. THEY NOTICED THAT THE PUSH BUTTON ON THE INNOVO BECAME DIFFICULT TO DEPRESS AND THE CIRCLE IN THE DISPLAY WINDOW DID NOT GO ALL THE WAY AROUND, ALTHOUGH THE PUSH BUTTON LOCKED. BLOOD GLUCOSE LEVELS PROGRESSIVELY INCREASED (140-215 MG/DL). PT FELT EXTREMELY WEAK AND DIZZY AND WAS UNABLE TO EAT OR TEST THEIR BLOOD GLUCOSE LEVELS. SINCE THEY WERE NOT EATING THEY DECREASED THE DOSE OF NOVOLOG PENFILL INSULIN FROM 5 UNITS TID TO 2 UNITS TID. THE NEXT DAY A NEIGHBOR BROUGHT THEM SOUP, BUT AFTER EATING IT THEY VOMITED. AT THAT POINT AN AMBULANCE WAS CALLED AND THEY WERE TAKEN TO THE EMERGENCY ROOM. THEIR BLOOD GLUCOSE LEVEL WAS 600 MG/DL AND THEY WERE STARTED ON AN INSULIN DRIP AND GIVEN INTRAVENOUS FLUIDS. THEY REMAINED IN THE HOSPITAL FOR FIVE DAYS AND WAS DISCHARGED WITH A NORMAL BLOOD GLUCOSE LEVEL. THE PT HAS EXPERIENCED DIABETIC KETOACIDOSIS SEVERAL TIMES IN THE PAST, THE LAST TIME APPROXIMATELY EIGHT YEARS AGO (TYPE OF INSULIN UNKNOWN). THEY HAD NO CHANGES IN DIET, ACTIVITY LEVEL OR HEALTH STATUS PRIOR TO HOSPITALIZATION. THE PT WAS TRAINED ON THE USE OF THE INNOVO BY THEIR PHYSICIAN. THEY DO AN AIR SHOT BEFORE EACH INJECTION, HOWEVER, THEY USE EACH DISPOSABLE NEEDLE (BRAND UNSPECIFIED) THREE TIMES. THEY STATED THAT THE DEVICE DID PASS THE FUNCTION CHECK. THE PT CONTINUES TO USE THE DEVICE IN QUESTION. THEY STATED THAT THEY DIAL TWO MORE UNITS THAN PRESCRIBED DOSE WITH EACH INJECTION AND SINCE THE EVENT THEIR BLOOD GLUCOSE LEVELS HAVE BEEN WELL CONTROLLED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 INNOVO INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS UNK UNK

Patients

Seq Age Sex Outcome Treatment
1 68 YR Hospitalization MEDICATION #1: 5 LU, TID, SUBCUTANEOUS 1)CATAPRES| - SLOW RELEASE (CLONIDINE HYDROCHLORIDE),| SUSPECT MEDICATION #1: NOVOLOG PENFILL 3 ML| 4) DISPOSABLE NEEDLE (NOT SPECIFIED).| (INSULIN ASPART) INJ. SOLUT., 100U/ML. SUSPECT| 2) CAPOTEN(CAPTOPRIL), 3) TRENTAL(PENTOXIFYLLINE),