BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOFINE 8MM (30G) AUTOCOVER

    MDR report key: 6788694 · Received August 11, 2017

    Report

    Report Number
    9681822-2017-00001
    Event Type
    Injury
    Date Received
    August 11, 2017
    Date of Event
    July 7, 2017
    Report Date
    July 18, 2017
    Manufacturer
    NOVO NORDISK A/S, MS HJOERRING
    Product Code
    FMI
    PMA / PMN Number
    K050106
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CASE DESCRIPTION: PATIENT'S HEIGHT, WEIGHT AND BMI: NOT REPORTED. INVESTIGATION RESULT: NAME: NOVOFINE AUTOCOVER TIP ETW 30G X 8MM, BATCH NUMBER: 15L11U A BATCH RECORD REVIEW ON INACCURATE DOSAGE WAS FOUND TO BE NORMAL. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. THE COMPLAINT HAS BEEN REGISTERED IN THE NOVO NORDISK COMPLAINT HANDLING SYSTEM. THE BATCH DOCUMENTATION WAS REVIEWED. NOTHING ABNORMAL WAS FOUND. MICROSCOPIC EXAMINATION PERFORMED. NEEDLES TESTED FOR SILICONE ON PATIENT NEEDLE NEEDLE POINTS EXAMINED VISUALLY FOR DEFECTS. FLOW RATE TEST TO DETERMINE THE FLOW THROUGH THE NEEDLE TUBE AN EXAMINATION OF A REFERENCE SAMPLE SHOWED NOTHING ABNORMAL. DURING INVESTIGATION IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES RELATED TO THE COMPLAINT ON A REFERENCE/RETAIN SAMPLE OF THE BATCH IN QUESTION. THE BATCH DOCUMENTATION HAS BEEN REVIEWED. NOTHING ABNORMAL WAS FOUND. SINCE LAST SUBMISSION, THE CASE HAS BEEN UPDATED WITH THE FOLLOWING : -SUSPECTED PRODUCT NOVOFINE 8MM (30G) AUTOCOVER BATCH NUMBER EXPIRATION DATE ADDED -INVESTIGATION RESULT ADDED -MANUFACTURER COMMENT ADDED -NARRATIVE UPDATED. MANUFACTURER COMMENT: 01-SEP-2017 : AS NOVOFINE 8MM (30G) AUTOCOVER HAS NOT BEEN RETURNED TO NOVO NORDISK A/S FOR INVESTIGATION AND ONLY VERY LIMITED INFORMATION REGARDING THE HANDLING OF SUSPECTED NOVOFINE 8MM (30G) AUTOCOVER IS REPORTED IN THIS CASE , IT IS NOT POSSIBLE TO IDENTIFY A CLEAR ROOT-CAUSE OF THE EXPERIENCED ADVERSE EVENT AND THUS FIND SIMILAR INCIDENTS TO THE ONE REPORTED IN ARGUS CASE 554981. EVALUATION SUMMARY NAME: NOVOFINE AUTOCOVER TIP ETW 30G X 8MM, BATCH NUMBER: 15L11U A BATCH RECORD REVIEW ON INACCURATE DOSAGE WAS FOUND TO BE NORMAL. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. THE COMPLAINT HAS BEEN REGISTERED IN THE NOVO NORDISK COMPLAINT HANDLING SYSTEM.THE BATCH DOCUMENTATION WAS REVIEWED. NOTHING ABNORMAL WAS FOUND. MICROSCOPIC EXAMINATION PERFORMED. NEEDLES TESTED FOR SILICONE ON PATIENT NEEDLE NEEDLE POINTS EXAMINED VISUALLY FOR DEFECTS. FLOW RATE TEST TO DETERMINE THE FLOW THROUGH THE NEEDLE TUBE AN EXAMINATION OF A REFERENCE SAMPLE SHOWED NOTHING ABNORMAL. DURING INVESTIGATION IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES RELATED TO THE COMPLAINT ON A REFERENCE/RETAIN SAMPLE OF THE BATCH IN QUESTION. THE BATCH DOCUMENTATION HAS BEEN REVIEWED. NOTHING ABNORMAL WAS FOUND.

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS) HIGH BLOOD SUGAR 18-31 MMOL/L [BLOOD GLUCOSE INCREASED] NEEDLES DOES NOT DELIVER CORRECT AMOUNT OF INSULIN [INCORRECT DOSE ADMINISTERED BY DEVICE] CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS REGULATORY AUTHORITY CASE RECEIVED VIA (B)(6) AND WAS REPORTED BY A CONSUMER AS "HIGH BLOOD SUGAR 18-31 MMOL/L" WITH AN ONSET DATE (B)(6) 2017, "NEEDLES DOES NOT DELIVER CORRECT AMOUNT OF INSULIN" WITH AN ONSET DATE (B)(6) 2017, AND CONCERNED A (B)(6) MALE PATIENT WHO WAS TREATED WITH NOVOFINE 8 MM (30 G) AUTOCOVER (NEEDLE) FROM (B)(6) 2017 DUE TO "DEVICE THERAPY". MEDICAL HISTORY WAS NOT PROVIDED. HISTORICAL TREATMENT INCLUDED NOVOFINE 30 G NEEDLES (NON-CODABLE). ON (B)(6) 2017, THE PATIENT'S BLOOD TESTS WHICH SHOWED LONG TERM AVERAGE INSULIN LEVELS AS 7.9 MMOL/L AND THE PATIENT WAS RENEWED PRESCRIPTION WAS PROVIDED WITH NOVOFINE AUTOCOVER 30 G NEEDLES INSTEAD OF NOVOFINE 30 G NEEDLES. AFTER THIS THE PATIENT'S BLOOD GLUCOSE INCREASED TO 18 TO 31 MMOL/L. LATER THE PATIENT WAS RETURNED TO NOVOFINE 30 G NEEDLES AND BLOOD SUGAR WAS STABILIZED AT 4 TO 12 MMOL/L. THE PATIENT WAS TRAINED IN USE OF NEEDLES AND DOES NOT REUSE NEEDLES. THE PATIENT DID NOT LEAVE NEEDLE ATTACHED TO PEN BETWEEN INJECTIONS AND DID NOT FEEL THE FORCE TO INJECT WAS DIFFERENT FROM NORMAL. THE PATIENT DID ENSURE NEEDLE WAS PROPERLY ATTACHED AND USED AT 180 DEGREE ANGLE. ACTION TAKEN TO NOVOFINE 8 MM (30 G) AUTOCOVER WAS REPORTED AS PRODUCT DISCONTINUED ON (B)(6)2017. THE OUTCOME FOR THE EVENT "HIGH BLOOD SUGAR 18-31 MMOL/L" WAS REPORTED AS RECOVERED ON (B)(6)2017. THE OUTCOME FOR THE EVENT "NEEDLES DOES NOT DELIVER CORRECT AMOUNT OF INSULIN" WAS NOT REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    CASE DESCRIPTION: INVESTIGATION RESULT: NAME: NOVOFINE AUTOCOVER TIP ETW 30G X 8MM, BATCH NUMBER: 15L11U THE BATCH DOCUMENTATION WAS REVIEWED. NOTHING ABNORMAL WAS FOUND. MICROSCOPIC EXAMINATION PERFORMED. NEEDLES TESTED FOR SILICONE ON PATIENT NEEDLE. NEEDLE POINTS ON PATIENT NEEDLES EXAMINED VISUALLY FOR DEFECTS. FLOW RATE TEST TO DETERMINE THE FLOW THROUGH THE NEEDLE TUBE AN EXAMINATION OF A REFERENCE SAMPLE SHOWED NOTHING ABNORMAL. DURING INVESTIGATION IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES RELATED TO THE COMPLAINT ON A REFERENCE/RETAIN SAMPLE OF THE BATCH IN QUESTION. THE BATCH DOCUMENTATION HAS BEEN REVIEWED. NOTHING ABNORMAL WAS FOUND. THE BATCH DOCUMENTATION WAS REVIEWED. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. MICROSCOPIC EXAMINATION PERFORMED. FLOW RATE TEST TO DETERMINE THE FLOW THROUGH THE NEEDLE TUBE THE PRODUCT WAS FOUND TO BE NORMAL. THE RESULTS WERE FOUND TO COMPLY WITH SPECIFICATIONS. DURING TEST IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES RELATED TO THE COMPLAINT ON THE UNUSED NEEDLES. SINCE LAST SUBMISSION, THE CASE HAS BEEN UPDATED WITH THE FOLLOWING : UPDATED INVESTIGATION RESULT ADDED, MANUFACTURER COMMENT UPDATED, NARRATIVE UPDATED. MANUFACTURER COMMENT: ON 22-SEP-2017 : SINCE NO FAULTS WERE FOUND ON THE RETURNED NEEDLES AND LIMITED INFORMATION REGARDING THE PATIENT'S HANDLING OF NEEDLES IS REPORTED IN THE CASE, IT IS NOT POSSIBLE TO ELUCIDATE A CLEAR ROOT CAUSE FOR THE EXPERIENCED ADVERSE EVENT AND THUS NOT POSSIBLE TO FIND SIMILAR INCIDENTS TO THE ONE REPORTED IN ARGUS CASE (B)(4). EVALUATION SUMMARY NAME: NOVOFINE AUTOCOVER TIP ETW 30G X 8MM, BATCH NUMBER: 15L11U THE BATCH DOCUMENTATION WAS REVIEWED. NOTHING ABNORMAL WAS FOUND. MICROSCOPIC EXAMINATION PERFORMED. NEEDLES TESTED FOR SILICONE ON PATIENT NEEDLE. NEEDLE POINTS ON PATIENT NEEDLES EXAMINED VISUALLY FOR DEFECTS. FLOW RATE TEST TO DETERMINE THE FLOW THROUGH THE NEEDLE TUBE AN EXAMINATION OF A REFERENCE SAMPLE SHOWED NOTHING ABNORMAL. DURING INVESTIGATION IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES RELATED TO THE COMPLAINT ON A REFERENCE/RETAIN SAMPLE OF THE BATCH IN QUESTION. THE BATCH DOCUMENTATION HAS BEEN REVIEWED. NOTHING ABNORMAL WAS FOUND. THE BATCH DOCUMENTATION WAS REVIEWED. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. MICROSCOPIC EXAMINATION PERFORMED. FLOW RATE TEST TO DETERMINE THE FLOW THROUGH THE NEEDLE TUBE THE PRODUCT WAS FOUND TO BE NORMAL. THE RESULTS WERE FOUND TO COMPLY WITH SPECIFICATIONS. DURING TEST IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES RELATED TO THE COMPLAINT ON THE UNUSED NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569546 NOVOFINE 8MM (30G) AUTOCOVER NEEDLE FMI NOVO NORDISK A/S, MS HJOERRING N/A 15L11U

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other