Description of Event or Problem · 1
INFORMATION REPORT: THIS DEVICE CASE, REPORTED BY A CONSUMER (VIA A COMPANY REPRESENTATIVE) AND CONCERNS THE CONSUMER WHO WAS RECEIVING HUMULIN M2 (20/80) AND HUMULIN N (NPH) VIA A PEN INJECTOR DEVICE (HUMAPEN ERGO). INDICATION FOR USE UNSPECIFIED. THE DEVICE WAS OPERATED BY THE PATIENT. THE PATIENT WAS A TRAINED USER. THE PATIENT HAD USED THE DEVICE FOR NINE MONTHS IN 2001.THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. IT WAS UNKNOWN WHETHER THE PATIENT WAS RECEIVING ANY CONCOMITANT MEDICATIONS. IN NOV-2001, IT WAS REPORTED BY THE PATIENT THAT PATIENT'S HUMAPEN ERGO (LOT# A1509/ MODEL#MS8930) 'FOOTPAD BROKE OFF AND THE INJECTION SCREW DOES NOT ADVANCE'. THE HUMAPEN WAS RETURNED TO THE COMPANY FOR ANALYSIS. INITIAL INSPECTION OF THE RETURNED DEVICE REVEALED: DETACHED FOOTPAD AND TWO BROKEN ENGAGEMENT TABS. THE PATIENT'S HUMAPEN WAS REPLACED. THE RETURNED HUMAPEN WAS FORWARDED TO THE MANUFACTURER (PDS FOR ANALYSIS DURING NOVEMBER 2001. NO ADVERSE EVENT WAS REPORTED IN CONNECTION WITH THIS COMPLAINT. THE DEVICE WAS RETURNED TO THE MANUFACTURER (PDS) FOR ANALYSIS. THE MANUFACTURER'S EVALUATION RESULTS REVEALED: THE SUSPECTED ROOT CAUSE FOR THE DEVICE FAILURE IS POST-PRODUCTION ABUSE FROM THE FIELD. THE PART DAMAGE IS CONSISTENT WITH THE ENGAGEMENT TABS BEING TRIMMED WITH A SHARP KNIFE. REVIEW OF HOUSE SAMPLES AND FMEA'S WAS NOT WARRANTED DUE TO THE NATURE OF THE DEVICE FAILURE. THE FAILURE MODE OBSERVED ON THIS DEVICE IS SUBSTANTIALLY DIFFERENT FROM THE FAILURE MODE OBSERVED FOR THE OPAQUE CARTRIDGE HOLDER TABS, WHICH USUALLY EXHIBITED A BRITTLE FAILURE SURFACE CONSISTENT WITH A SUSTAINED STRESS FRACTURE AND CRACK PROPAGATION.