Description of Event or Problem · 1
TROUBLE BREATHING[DYSPNOEA], PROBLEM WITH DELIVERY OF SEVERAL DEVICES; HIGH BLOOD SUGARS; BLOOD SUGARS "BOTTOMED-OUT (LOW BLOOD SUGAR); TROUBLE BREATHING [DEVICE MALFUNCTION], HIGH BLOOD SUGARS[BLOOD GLUCOSE INCREASED], BLOOD SUGARS "BOTTOMED-OUT" (LOW BLOOD SUGAR)[BLOOD GLUCOSE DECREASED]. CASE DESCRIPTION: MEDICAL DEVICE INFORMATION: CLASS IIB. THIS SPONTANEOUS REPORT, REPORTED BY A CONSUMER (PATIENT'S MOTHER), FROM THE UNITED STATES, REPORTED AS "PROBLEM WITH DELIVERY OF SEVERAL DEVICES; HIGH BLOOD SUGARS; BLOOD SUGARS "BOTTOMED-OUT (LOW BLOOD SUGAR); TROUBLE BREATHING," CONCERNS A (B)(6) FEMALE TREATED WITH A NOVOPEN JUNIOR (INSULIN DELIVERY DEVICE) FOR TYPE 1 DIABETES MELLITUS. MEDICAL HISTORY INCLUDED ANXIETY AND HASHIMOTO'S THYROIDITIS (AUTO-IMMUNE). THE PATIENT'S HEIGHT WAS (B)(6). THE MOTHER REPORTED THAT THROUGHOUT THE DAY ON (B)(6) 2009, SHE WAS HAVING DELIVERY PROBLEMS WITH SEVERAL NOVOPEN JUNIORS AND HER DAUGHTER'S BLOOD SUGARS WERE RUNNING VERY HIGH OVER 600 MG/DL. HER DAUGHTER'S GLUCOMETER WAS NOT REGISTERING. THROUGHOUT THE ENTIRE DAY, THE MOTHER TREATED THE EXTREMELY HIGH BLOOD SUGARS WITH HER DAUGHTER'S CURRENT NOVOLOG (INSULIN ASPART) DOSAGE OF 16 IU BEFORE MEALS, INTERMITTENT SLIDING SCALE DOSAGES OF NOVOLIN R (INSULIN HUMAN), AND LANTUS (INSULIN GLARGINE) 32 IU AT NIGHT, AS PRESCRIBED. HER DAUGHTER'S BLOOD SUGARS PERSISTENTLY REMAINED ELEVATED DESPITE CONTINUOUS AND MULTIPLE AMOUNTS OF INSULIN THERAPIES; THEREFORE, SHE TRANSPORTED HER DAUGHTER TO THE EMERGENCY ROOM AT 11 PM THAT SAME DAY. IN THE EMERGENCY ROOM, THE BLOOD SUGARS WERE IN THE 800-900'S MG/DL. THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS (SPECIFICS UNKNOWN) AND MONITORED CLOSELY. THE MOTHER STATED THAT HER DAUGHTER DID NOT RECEIVE AN INSULIN DRIP OR ANY ADDITIONAL SUBCUTANEOUS INSULIN THERAPIES BECAUSE OF THE MULTIPLE AMOUNTS OF INSULIN RECEIVED EARLIER THROUGHOUT THE DAY. WHILE IN THE EMERGENCY ROOM, HER DAUGHTER'S BLOOD SUGARS DECREASED RAPIDLY TO 271 MG/DL AND SUBSEQUENTLY "BOTTOMED-OUT" (LOW BLOOD SUGAR) TO 66 MG/DL. THE PATIENT EXPERIENCED TROUBLE BREATHING. THE PATIENT'S INTRAVENOUS FLUID RATE WAS INCREASED, OXYGEN THERAPY ADMINISTERED, AND SHE WAS GIVEN ORANGE JUICE. AFTER TREATMENT, THE PATIENT'S BLOOD SUGARS INCREASED IN THE 200'S MG/DL AND SHE STABILIZED. THE PATIENT'S TROUBLE BREATHING AND LOW BLOOD SUGARS RESOLVED. BY EARLY MORNING ON (B)(6) 2009, THE PATIENT WAS DISCHARGED FROM THE EMERGENCY ROOM ON CURRENT INSULIN THERAPIES. THE MOTHER REPORTED THAT HER DAUGHTER WAS SEEN IN THE EMERGENCY ROOM (LESS THAN 24 HOURS) AND WAS NOT ADMITTED TO THE HOSPITAL FOR THE EVENTS. ON (B)(6) 2009, THE PATIENT'S BLOOD SUGARS IMPROVED AND RANGED BETWEEN 163 TO 180'S MG/DL AND 217 MG/DL ON (B)(6) 2009. AT THE TIME OF THIS REPORT, THE MOTHER STATED THAT SHE WAS TOO APPREHENSIVE ABOUT USING THE NOVOPEN JUNIOR'S AGAIN AND SWITCHED HER DAUGHTER TO VIAL AND SYRINGES. OVERALL OUTCOME WAS REPORTED AS "RECOVERING/RESOLVING " FOR THE EVENT OF HIGH BLOOD SUGARS; "NOT RECOVERED" FOR THE EVENT OF PROBLEM WITH DEVICE DELIVERY; AND "RECOVERED" ON (B)(6) 2009 FOR THE EVENTS OF BLOOD SUGARS BOTTOMED-OUT (LOW BLOOD SUGAR) AND TROUBLE BREATHING. THE MOTHER REPORTED THAT SHE DID NOT EXPERIENCE ANY PROBLEMS WITH NOVOLOG PENFILL CARTRIDGES, NOVOLIN R, AND LANTUS INSULINS. THE MOTHER REPORTED THAT HER DAUGHTER DID NOT EXPERIENCE AN UNEXPECTED INCREASE IN INSULIN REQUIREMENTS. THE PATIENT DID NOT HAVE ANY RECENT CHANGES IN DIET, ACTIVITY, OR HEALTH STATUS, PRIOR TO ONSET OR DURING THE EVENT. THE PATIENT HAD NO EVIDENCE OF INFECTIONS. THE PATIENT DID NOT START ON ANY NEW PRODUCTS PRIOR TO THE ONSET OR DURING THE EVENT. THE MOTHER STATED THAT SHE WAS NOT AWARE OF DOING AIR SHOTS. IT WAS UNKNOWN IF THE DISPOSABLE NEEDLES ARE REMOVED IMMEDIATELY AFTERWARDS AND IF THE NEEDLES ARE RE-USED. COMMENT: COMPANY COMMENT - THIS PATIENT EXPERIENCED TROUBLE BREATHING (DYSPNEA) WHILE HAVING A HYPOGLYCEMIC EVENT, AND THE EVENT RESOLVES WHEN THE BLOOD SUGAR NORMALIZES. IN ADDITION, THE PATIENT HAS A MEDICAL HISTORY ANXIETY. SEVERE HYPOGLYCEMIA CAN AFFECT CEREBRAL FUNCTION AND TOGETHER WITH THE MEDICAL HISTORY OF ANXIETY, THIS MAY WELL HAVE CONTRIBUTED TO THE EVENT OF DYSPNEA.