BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMAPEN ERGO, TEAL/CLEAR

    MDR report key: 5311057 · Received August 16, 2004

    Report

    Report Number
    1819470-2004-00020
    Event Type
    Other
    Date Received
    August 16, 2004
    Report Date
    August 16, 2004
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    NSC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER PRELIMINARY COMMENTS: UPON RETURN OF THE DEVICE, AN EVALUATION WILL BE PERFORMED TO DETERMINE IF A MALFUNCTION HAS OCCURRED. ADDITIONAL MANUFACTURER NARRATIVE: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE FINAL EVALUATION IS COMPLETED. THIS REPORT IS ASSOCIATED WITH 1819470-2004-00019, SINCE THERE IS MORE THAN ONE DEVICE IMPLICATED WITH THE ADVERSE EVENT.

    Description of Event or Problem · 1

    THIS CASE, REPORTED BY A NON-HEALTHCARE PROFESSIONAL WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT, CONCERNS A (B)(6) FEMALE PT. THE PT'S MEDICAL HISTORY INCLUDED DIABETES FOR 24 YEARS AND UNSPECIFIED CHOLESTEROL PROBLEMS. CONCOMITANT MEDICATION INCLUDED METFORMIN, PRAVASTATIN, ENALAPRIL AND ASPIRIN 'TO THIN THE BLOOD'. THE REPORTER STATED THAT THE PT WAS ON ONE-A-DAY BUT THE PT'S LEG BECAME SWOLLEN SO THE PT'S DOCTOR INCREASED THE DOSE TO TWO-A-DAY APPROXIMATELY SIX-MONTHS PRIOR TO REPORTING (ESTIMATED TO BE DURING (B)(6) 2004). THE PATIENT RECEIVED 30% SOLUBLE INSULIN/70% ISOPHANE INSULIN (HUMULIN M3), 26 UNITS IN THE MORNING AND 10 UNITS IN THE EVENING, DELIVERED VIA TWO HUMAPEN ERGO TEAL/CLEAR PEN BODIES (LOT UNKNOWN), WITH CLEAR CARTRIDGE HOLDERS ATTACHED, FOR THE TREATMENT OF DIABETES, BEGINNING APPROXIMATELY 5 YEARS PRIOR TO REPORTING (ESTIMATED TO BE DURING 1999). DURING (B)(6) 2003, WHILST RECEIVING THERAPY WITH 30% SOLUBLE INSULIN/70% ISOPHANE INSULIN. THE PATIENT HAD A BLADDER OPERATION (REASON NOT PROVIDED). THE REPORTER STATED THAT SINCE THE OPERATION THE PATIENT HAD NOT BEEN KEEPING TOO WELL. THE PATIENT HAD ENTHESITIS (REPORTED AS ENTHROSITIS) IN HER LEGS, WHICH THE REPORTER STATED OCCURRED POST-OPERATION. ON AN UNSPECIFIED DATE THE PATIENT HAD A CAT SCAN, WHICH SHOWED NOTHING IN HER LEGS. ON (B)(6) 2004, THE REPORTER STATED THAT THE PATIENT WENT ON HOLIDAY ABROAD AND EXPERIENCED HIGH BLOOD SUGARS WHILST SHE WAS AWAY. THE PATIENT'S BLOOD SUGARS WENT UP TO 24 AND SHE TWICE BLACKED OUT COMPLETELY. THE PATIENT'S NORMAL BLOOD SUGARS WERE 7-8. "THE REPORTER STATED THAT THE FRIDGE ON HOLIDAY HAD NOT SEEMED TO KEEP ITEMS COOL ENOUGH AS THE MILK HAD KEPT GOING OFF." THE REPORTER STATED THAT THE PATIENT HAD CARRIED THE 30% SOLUBLE INSULIN/70% ISOPHANE INSULIN NEXT TO A FREEZER PACK WHILST TRAVELING. THE PATIENT RETURNED FROM HOLIDAY ON (B)(6) 2004 AND THE REPORTER STATED THAT THE PATIENT'S BLOOD SUGARS REMAINED ON THE HIGH SIDE FOR THE NEXT TWO-WEEKS UNTIL APPROXIMATELY (B)(6) 2004. THE PATIENT WAS STILL USING THE SAME INSULIN, WHICH SHE HAD BEEN USING WHILST ON HOLIDAY. THE REPORTER ALSO STATED THAT THE PATIENT'S LEGS BECAME SWOLLEN DURING TRAVEL AND THE PATIENT HAD WONDERED IF THIS WAS BECAUSE SHE HAD BEEN ADVISED TO 'WEAR SOME TAPE' ON HER LEGS FOR TRAVELLING. THE REPORTER STATED THAT ALTHOUGH THE PATIENT'S BLOOD SUGARS RETURNED TO NORMAL AFTER 2 WEEKS, THE PATIENT HAD EXPERIENCED A FEW HIGH READINGS IN THE WEEKS PRIOR TO REPORTING, AROUND 13. THE PATIENT'S BLOOD SUGARS WERE 13 ON THE MORNING OF (B)(6) 2004. THE REPORTER STATED THAT THIS WAS BEING MONITORED. THE REPORTER STATED THAT THE CAPS WOULD NOT GO ON THE PATIENT'S HUMAPENS AT ALL. THE REPORTER THOUGHT THAT THIS WAS DUE TO THE NEW CARTRIDGES. THE PERSON OPERATING THE DEVICES WAS THE PATIENT WHO WAS A TRAINED USER. THE PATIENT USED 12.7MM NOVO NORDISK NEEDLES AND DID NOT REUSE EACH NEEDLE. THE PATIENT PRIMED THE PEN, INJECTED INTO HER ABDOMEN AND DID NOT HOLD THE NEEDLE IN THE SKIN AFTER INJECTING. THE DEVICES WERE 6 MONTHS OLD AND WERE STORED INSIDE. AT THE TIME OF REPORTING THE PATIENT HAD NOT RECOVERED FROM HIGH BLOOD SUGARS, NOT FEELING WELL AND ENTHESITIS AND WAS RECOVERING FROM THE BLADDER OPERATION. IT WAS UNKNOWN IF THE PATIENT HAD RECOVERED FORM THE SWOLLEN LEGS AND BLACKING OUT. THERAPY WITH 30% SOLUBLE INSULIN/70% ISOPHANE INSULIN CONTINUES. THIS HUMAPEN ERGO COMPLAINT IS ASSOCIATED WITH (B)(6). THESE EVENTS ARE UNASSESSED BY A HEALTHCARE PROFESSIONAL. THE DEVICES ARE DUE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. EDIT 08/25/2004: FOLLOWING REVIEW BY GPS AE OF BLACKED OUT WAS UPGRADED TO OTHER REASON SERIOUS. CASE UPDATED ACCORDINGLY. EDIT 08/26/2004: DEVICE EVENT OF BLACKED OUT WAS UPGRADED TO OTHER REASON SERIOUS. UPDATE 08/26/2004: UPON REVIEW OF CASE, CHANGED SERIOUSNESS OF BLADDER OPERATION FROM NON-SERIOUS TO HOSPITALISED. CHANGED ADDITIONAL NARRATIVE PHRASE FOR BOTH DEVICES. MADE GRAMMATICAL CORRECTIONS TO NARRATIVE. CASE UPDATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, TEAL/CLEAR PEN INJECTOR NSC ELI LILLY AND CO. MS8929 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other