Description of Event or Problem · 1
UNCONTROLLED BLOOD GLUCOSE [DIABETES MELLITUS INADEQUATE CONTROL]. THE PISTON ROD COULD NOT BE MOVED [DEVICE MALFUNCTION]. THE MEDICATION COULD NOT BE INJECTED [DEVICE FAILURE]. CASE DESCRIPTION: THIS SERIOUS REGULATORY AUTHORITY SPONTANEOUS CASE RECEIVED VIA NMPA (NATIONAL MEDICAL PRODUCTS ADMINISTRATION), CHN FROM (B)(4) WAS REPORTED BY A HEALTH CARE PROFESSIONAL AS "UNCONTROLLED BLOOD GLUCOSE(LOSS OF CONTROL OF BLOOD SUGAR)" BEGINNING ON (B)(6) 2020, "THE PISTON ROD COULD NOT BE MOVED(DEVICE COMPONENT MALFUNCTION)" BEGINNING ON (B)(6) 2020, "THE MEDICATION COULD NOT BE INJECTED(DEVICE FAILURE)" BEGINNING ON (B)(6) 2020, AND CONCERNED A (B)(6) FEMALE PATIENT WHO WAS TREATED WITH NOVOPEN 5 (INSULIN DELIVERY DEVICE) FROM (B)(6) 2020 FOR "DIABETES MELLITUS", NOVOLIN N (INSULIN HUMAN; REPORTED AS NOVOLIN) SUSPENSION FOR INJECTION, 100 IU/ML (DOSE, FREQUENCY & ROUTE USED - UNK, UNKNOWN) FROM UNKNOWN START DATE FOR "DIABETES MELLITUS", THE PATIENT'S HEIGHT, WEIGHT AND BODY MASS INDEX WERE NOT REPORTED. DOSAGE REGIMENS: NOVOPEN 5: (B)(6) 2020 TO NOT REPORTED; CURRENT CONDITION: DIABETES MELLITUS (TYPE AND DURATION NOT REPORTED) ON (B)(6) 2020, AT 9, DUE TO DIABETES MELLITUS, THE PATIENT WAS HOSPITALIZED TO LOWER BLOOD GLUCOSE. THE EXPECTED TREATMENT WAS INJECTING NOVOLIN TO LOWER BLOOD GLUCOSE. THE PATIENT USED INSULIN PEN DIGITAL DISPLAY SYRINGE. AT 9, WHEN ADJUSTING THE INJECTION, THE PISTON ROD COULD NOT BE MOVED AND MEDICATION COULD NOT BE INJECTED, WHICH CAUSED THE PATIENT'S UNCONTROLLED BLOOD GLUCOSE (VALUE AND UNIT NOT REPORTED). AFTER REMOVING THE CARTRIDGE HOLDER AND PUSHING THE DOSE BUTTON, THE PISTON ROD DID NOT MOVE. IT COULD NOT BE DETERMINED WHETHER IT WAS CAUSED BY PRODUCT ISSUE OR IMPROPER HANDLING. THE HOSPITALIZATION WAS PROLONGED DUE TO THE UNCONTROLLED BLOOD GLUCOSE. AT 9:05, AFTER CHANGING TO A NEW INSULIN PEN DIGITAL DISPLAY SYRINGE FOR TREATMENT, BLOOD GLUCOSE WAS CONTROLLED (VALUE AND UNIT NOT REPORTED). BATCH NUMBER OF NOVOPEN 5 AND NOVOLIN WAS NOT REPORTED. ACTION TAKEN TO NOVOPEN 5 WAS NOT REPORTED. ACTION TAKEN TO NOVOLIN N WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "UNCONTROLLED BLOOD GLUCOSE(LOSS OF CONTROL OF BLOOD SUGAR)" WAS RECOVERING/RESOLVING. THE OUTCOME FOR THE EVENT "THE PISTON ROD COULD NOT BE MOVED(DEVICE COMPONENT MALFUNCTION)" WAS RECOVERING/RESOLVING. THE OUTCOME FOR THE EVENT "THE MEDICATION COULD NOT BE INJECTED(DEVICE FAILURE)" WAS NOT REPORTED. NO FURTHER INFORMATION AVAILABLE. INVESTIGATION RESULT: NAME: NOVOPEN 5. BATCH NUMBER: KUGX988-1. NO CONCLUSION CAN BE MADE WITHOUT THE SAMPLE OR A VALID BATCH NUMBER. THE REPORTED BATCH NUMBER WAS NOT VALID. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. NAME: NOVOLIN, BATCH NUMBER: UNKNOWN, NO INVESTIGATION WAS POSSIBLE, BECAUSE NEITHER SAMPLE NOR BATCH NUMBER WAS AVAILABLE. REFERENCES INCLUDED: REFERENCE TYPE: E2B REPORT DUPLICATE; REFERENCE ID#: (B)(4); REFERENCE NOTES: NMPA (NATIONAL MEDICAL PRODUCTS ADMINISTRATION), CHN; REFERENCE TYPE: E2B COMPANY NUMBER; REFERENCE ID#: (B)(4); FINAL MANUFACTURER'S COMMENT: 23-DEC-2020: THE SUSPECTED DEVICE NOVOPEN 5 HAS NOT BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. THE REPORTED BATCH NUMBER IS NOT VALID. BATCH TREND ANALYSIS NOT PERFORMED. WITH LIMITED INFORMATION REGARDING THE HANDLING OF SUSPECTED DEVICE, IT IS NOT POSSIBLE TO IDENTIFY A CLEAR ROOT-CAUSE OF THE EXPERIENCED ADVERSE EVENTS. THIS REPORT IS FOR A FOREIGN DEVICE THAT IS ASSESSED AS "SIMILAR" TO US MARKETED NOVOPEN ECHO. INVESTIGATION RESULT: NAME: NOVOPEN 5, BATCH NUMBER: KUGX988-1, NO CONCLUSION CAN BE MADE WITHOUT THE SAMPLE OR A VALID BATCH NUMBER. THE REPORTED BATCH NUMBER IS NOT VALID. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION.