Description of Event or Problem · 1
HYPERGLYCAEMIA DUE TO DEVICE FAILURE [HYPERGLYCAEMIA]. CASE DESCRIPTION: TRIAL ID: (B) (4). TRIAL TITLE: (B) (4), TRIAL COMPARING THE EFFICACY AND SAFETY OF INSULIN DETEMIR (LEVEMIR) VERSUS HUMAN INSULIN (NPH INSULIN), USED IN COMBINATION WITH INSULIN ASPART AS BOLUS INSULIN, IN THE TREATMENT OF PREGNANT WOMEN WITH TYPE 1 DIABETES. PHASE: 3B: INVESTIGATIONAL DRUGS: INSULIN DETEMIR (LEVEMIR), 100 U/ML, 3 ML CARTRIDGE VS. HUMAN ISOPHANE INSULIN (NPH INSULIN), 100 U/ML, 3 ML CARTRIDGE. INSULIN ASPART, 100 U/ML, 3 ML CARTRIDGE AS BOLUS INSULIN. PATIENT ID: (B) (6). THIS CLINICAL TRIAL CASE FROM THE (B) (6) WAS REPORTED AS "HYPERGLYCAEMIA DUE TO DEVICE FAILURE" AND CONCERNS A (B) (6) FEMALE PATIENT. THE PATIENT WAS RANDOMISED ON (B) (6) 2007, PREGNANT AT (B) (6), AND WAS TREATED WITH SUSPECTED TRIAL DEVICE NOVOPEN 3, SUSPECTED TRIAL DRUG NOVORAPID PENFILL 3.0 ML (FAST ACTING INSULIN ASPART) FROM (B) (6) 2007, AND ONGOING, AND OTHER SUSPECTED PRODUCT LEVEMIR PENFILL (INSULIN DETEMIR) FROM (B) (6) 2007, AND ONGOING FOR DIABETES MELLITUS INSULIN DEPENDENT. AT VISIT 1 THE GLYCOSYLATED HAEMOGLOBIN WAS 6.2% THEREFORE EXCELLENT CONTROL. AT SCREENING, THE PATIENT WAS TREATED WITH INSULIN ASPART AND INSULIN GLARGINE. ON (B) (6) 2008, AT (B) (6), THE PATIENT EXPERIENCED HYPERGLYCAEMIA DUE TO DEVICE FAILURE OF NOVOPEN 3 CONTAINING INSULIN DETEMIR. THE PATIENT VISITED THE HOSPITAL THE DAY BEFORE AND ON THE DAY OF THE EVENT, IN AN ATTEMPT TO HELP IMPROVE HER BLOOD GLUCOSE LEVEL AS SHE WAS TITRATING HER INSULIN DOSE UPWARDS WITH NO APPARENT EFFECT. BLOOD GLUCOSE LEVELS WERE NOTICEABLY RAISED UP TO 10-13 MMOL/L FROM (B) (6) 2008 TO (B) (6) 2008. PRIOR TO THIS, BLOOD GLUCOSE LEVEL WAS 4.9 MMOL/L. THE NOVOPEN 3 THAT WAS BEING USED TO DELIVER INSULIN DETEMIR WAS CHECKED BY A DIABETES NURSE SPECIALIST AND IT WAS SUSPECTED THAT THE PEN WAS NOT DELIVERING THE CORRECT AMOUNT. FUNCTIONING OF NOVOPEN WAS DETERMINED BY SETTING THE PEN TO 25U AND FILLING THE NEEDLE CAP. IT WAS DISCOVERED THAT THE AMOUNT DELIVERED DID NOT REGISTER AT CORRECT LEVEL. THIS WAS COMPARED TO A NEW PEN WHICH DID REGISTER A CORRECT LEVEL. THE PATIENT ALSO HAD A SUSPECTED URINARY TRACT INFECTION. A MIDSTREAM SPECIMEN OF URINE (MSU) WAS FOUND TO BE NEGATIVE. THE PATIENT WAS GIVEN A NEW NOVOPEN 3 AND WAS TREATED WITH CEGRADINE 250 MG (NOT ABLE TO BE CODED). THE PATIENT WAS CONSIDERED NOT RECOVERED FROM THE EVENT. ON (B) (6) 2008, URINE WAS CHECKED FOR KETONES BY WARD STAFF AND WAS NEGATIVE. ON (B) (6) 2008, 2 SUBSEQUENT KETONE CHECKS BY THE PATIENT AT HOME WERE BOTH NEGATIVE. UPON FURTHER DISCUSSIONS WITH THE PRINCIPAL INVESTIGATOR AT THE SITE, HE FELT THAT THIS WAS A SERIOUS ISSUE AS THE PATIENT WAS PREGNANT AND HER PREGNANCY HAD BEEN PLACED AT RISK AS A CONSEQUENCE OF THE SUSPECTED FAULTY PEN. BECAUSE OF THIS, IT WAS DECIDED ALSO TO REPORT THE EVENT AS A SERIOUS ADVERSE EVENT OF HYPERGLYCAEMIA DUE TO FAULTY DEVICE. THE NOVORAPID TITRATION DOSES COULD NOT BE ENTERED IN THE CASE, THEREFORE THE DOSES ARE DESCRIBED BELOW: ON (B) (6) 2007, THE PATIENT RECEIVED 10-12 UNITS. ON (B) (6) 2008, THE DOSE WAS INCREASED TO 14-16 UNITS. ON (B) (6) 2008, THE DOSE WAS INCREASED TO 15-17 UNITS. THE DOSES OF BOTH TRIAL DRUGS WERE INCREASED DUE TO THE EVENT. THE DEVICE WAS RETURNED TO NOVO NORDISK AND THE ANALYSIS IS PENDING. INVESTIGATOR'S CAUSALITY: NOVORAPID PENFILL 3.0 ML (FAST ACTING INSULIN ASPART): UNLIKELY. LEVEMIR PENFILL (INSULIN DETEMIR): UNLIKELY; NOVOPEN 3: UNKNOWN. SPONSOR'S CAUSALITY: NOVORAPID PENFILL 3.0 ML (FAST ACTING INSULIN ASPART): POSSIBLE; LEVEMIR PENFILL (INSULIN DETEMIR): POSSIBLE; NOVOPEN 3: POSSIBLE. MEDICAL DEVICE INFORMATION: CLASS IIB. THE PATIENT HAS ANOTHER (B) (4) REPORTED IN LIKED CASE (B) (4) (VOMITING). COMMENT: COMPANY COMMENT: THE SPONSOR DISAGREES WITH THE INVESTIGATOR CONCERNING THE CAUSALITY OF THE SUSPECTED PRODUCTS AS IT CANNOT BE EXCLUDED THAT THE INSULIN DOSES DELIVERED HAVE BEEN TOO LOW, EITHER DUE TO THE INSULINS OR DUE TO THE DEVICE.