Description of Event or Problem · 1
THE PT RECEIVED 30% SOLUBLE INSULIN / 70% ISODPHANE INSULIN (HUMULN M3), 26 UNITS IN THE MORNING AND 16 UNITS IN THE EVENING, DELIVERED VIA A HUMAPEN ERGO (TWO DEVICES RETURNED ONE TEAL CLEAR PEN BODY LOT 40213, AND ONE BURGENDY CLEAR PEN BODY LOT 40256), WITH A CLEAR CARTRIDGE HOLDER ATTACHED, FOR THE TREATMENT OF DIABETES (NO START DATE PROVIDED). THE REPORTER STATED THAT THE PT HAS HAD REPEATED ADMISSIONS TO HOSP WITH DIABETIC KETOACIDOISIS AND CONTROLLED DIABETS (DATES UNK). THE PATIENT WAS DESCRIBED AS BEING VERY ILL AND BECAME A 'BAG OF BONES'. THE REPORTER STATED THAT THE PT WAS HOSPITALIZED AT THE END OF MAR-2004 FOR DIABETIC KETOACIDOSIS BUT BELIEVED THE PT HAD BEEN HOSPITALIZED MORE THAN ONCE SINCE CHRISTMAS (DEC-2003). THE PT WAS REFERRED TO A DIABETES NURSE WHO LOOKED AT THE HUMPEN AND THOUGHT THAT THERE WAS SOMETHING WRONG WITH THE PEN. THE PT WAS CHANGED TO AN AUTOPEN AND THE PT'S BLOOD SUGARS SETTLED DOWN AND THERE HAVE BEEN NO FURTHER REPORTS OF DIABETIC KETOACIDOSIS. THE PT IS DUE TO VISIT THE CLINIC AGAIN IN JUN-2004. THE PERSON OPERATING THE DEVICE WAS THE PT AND IT WAS UNK IF THEY WERE TRAINED USER. AT THE TIME OF REPORTING THE PT BLOOD SUGARS WERE REPORTED TO HAVE SETTLED DOWN. IT WAS UNK IF THERAPY WITH 30% SOLUBLE INSULIN / 70% ISOPHANE INSULIN CONTINUES. THIS HUMAPEN ERGO COMPLAINT IS ASSOCIATED WITH CID00244682 AND CID00246969. TWO DEVICES WERE RETURNED TO THE CO FOR EVALUATION. THE DEVICES ARE BEING SENT TO THE MFR FOR ADDITIONAL EVALUATION AND CONCLUSION IS PENDING. UPDATE MAY-2004: UPON REVIEW OF SOURCE DOCUMENTATION, ADDITIONAL REPORTER AND CONTACT ADDED AND HUMAPEN TYPE CHANGED TO UNK CARTRIDGE HOLDER TYPE IN NARRATIVE. UPDATE A WEEK LATER: TWO DEVICES WERE RETURNED TO THE CO IN MAY 2004. AS IT IS NOT KNOWN WHICH DEVICE WAS IMPLICATED IN THE EVENT, BOTH DEVICES HAVE BEEN ENTERED AS SUSPECT DEVICES. ADDED DATE RETURNED AND LOT NUMBERS. DEVICE PAGE AND NARRATIVE UPDATED ACCORDINGLY.