BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI LANCER

    MDR report key: 1912056 · Received December 1, 2010

    Report

    Report Number
    2939301-2010-10400
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 6, 2010
    Report Date
    November 8, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2010: THE MSS SPOKE TO THE PATIENT AND OBTAINED/VERIFIED THE FOLLOWING INFORMATION. THE PATIENT INFORMED THE MSS THAT HIS TESTING FREQUENCY IS 1-2 TIMES A WEEK. THE PATIENT CLARIFIED HE EXPERIENCE THE SYMPTOM OF SHAKY. THE PATIENT SELF TREATED WITH GLUCOSE TABLETS AND RESTED. THE PATIENT CLAIMED 1/2 HOUR LATER HE FELT BETTER. THE CLASSIFICATION OF THIS REPORT REMAINS UNCHANGED.

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN RESPONSE TO (B)(6) HOSPITAL'S (B)(6) RECEIVED ON AUGUST 9TH, 2010. (B)(6) RE-IN SERVICED THE OPERATING ROOM NURSING STAFF ON (B)(6) 2010 ON HOW TO PROPERLY OPERATE THE EMERGENCY BRAKE RELEASE. THE OPERATING ROOM STAFF AGREED THAT THE TABLE DID NOT FAIL. ONE OF THE STAFF, BY MISTAKE, OPENED UP THE EMERGENCY BRAKE RELEASE VALVE. DURING THE OPERATING ROOM PROCEDURE, NO ONE REALIZED THAT THE BRAKE SYSTEM HAD BEEN OPENED. THERE WAS A PT ON THE TABLE WHEN THIS HAPPENED AND WAS NOT INJURED OR COMPROMISED. (B)(6) REP RE-IN SERVICED ALL THE SHIFTS IN LABOR AND DELIVERY ON (B)(6) 2010 AND MADE SURE THAT ALL NURSING STAFF WERE PROPERLY EDUCATED WITH OUR 6701 TABLE, AND THE ACCESSORIES ASSOCIATED WITH THE TABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THERE WERE MISSING LANCETS FROM THE ONETOUCH LANCING DEVICE KIT (MINI LANCER). THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CONTACTED THE PATIENT ON (B)(6) 2010 FOR A FOLLOW UP CALL; HOWEVER THE PATIENT WAS NOT ABLE TO BE REACHED. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON THE AFTERNOON OF (B)(6) 2010 AT AN UNSPECIFIED TIME. THE PATIENT CLAIMED HE WAS NOT ABLE TO TEST ON HIS METER AS A RESULT OF THE ISSUE. THE PATIENT INFORMED THE CCA THAT HE MANAGES HIS DIABETES WITH ORAL MEDICATIONS AND DIET/EXERCISE. THE FOLLOWING DAY IN THE AFTERNOON, THE PATIENT CLAIMED HE INCREASED HIS DOSE OF AN UNKNOWN ORAL MEDICATION TO 2 TABLETS. A DAY AFTER THE ALLEGED ISSUE BEGAN, HE CLAIMED HE DEVELOPED SYMPTOMS OF DRY MOUTH, HIS LEGS WERE HURTING, AND WAS SHIVERING. IN SPITE OF THE SYMPTOMS, THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA VERIFIED THERE WERE MISSING LANCETS FROM THE KIT. REPLACEMENT PRODUCTS WERE STILL SENT TO THE PATIENT. IT IS NOT KNOWN WHETHER THE PATIENT ASSOCIATED THE SYMPTOM OF SHIVERING AS HIGH OR LOW BLOOD SUGAR SYMPTOMS. THEREFORE, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI LANCER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening