BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1871786 · Received October 15, 2010

    Report

    Report Number
    2954323-2010-01439
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 15, 2010
    Report Date
    July 14, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S PRODUCTS WERE RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READING THE CUSTOMER REPORTED WAS FOUND IN METER MEMORY. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (B)(6) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER ON FOLLOW-UP #1 SHOULD HAVE REFLECTED THE DATE OF (B)(6) 2010. AS PER THE ARRANGEMENTS DISCUSSED WITH (B)(4) AT FDA, THIS MDR IS BEING SUBMITTED FOR CORRECTION AS EXPLAINED TO THE AGENCY IN A (B)(4) 2011 LETTER ADDRESSED TO (B)(6).

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE UNPACKING THE PROMUS STENT DELIVERY SYSTEM (SDS) THE STENT WAS FOUND TO BE FAULTY, AS IT WAS NOT MOUNTED ON THE SDS CORRECTLY. THE SDS WAS NOT USED IN THE PATIENT. THERE WERE NO OTHER PACKAGES WITH THE SAME LOT NUMBER IN THE ORGANIZATION. ANOTHER STENT WAS USED. HEALTH PROFESSIONAL'S IMPRESSION: STENT WAS NOT MOUNTED PROPERLY. NO ADDITIONAL INFORMATION WAS PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    A PATIENT CONTACTED (B)(6) REGARDING ASSISTANCE WITH A LOW DRAIN VOLUME ALARM WHILE USING THE HOMECHOICE (HC) DURING THERAPY, IN THE INITIAL DRAIN CYCLE. (B)(4) REVIEWED THE DRAIN VOLUME (46ML) AND THE LAST FILL VOLUME (500ML) AND ASKED THE PATIENT IF SHE KNEW WHEN SHE WAS EMPTY. THE PATIENT SAID YES, SHE GETS DRAIN PAINS. (B)(4) THEN ASKED THE PATIENT IF SHE WAS EMPTY AND THE PATIENT SAID NO. THE PATIENT STATED THAT SHE SAW AN AIR BUBBLE IN THE PATIENT LINE. (B)(4) HAD THE PATIENT START THE DRAIN TO DRAIN MORE SOLUTION, BUT THE PATIENT WAS UNABLE TO. THE PATIENT STATED SHE WANTED TO START OVER WITH NEW SUPPLIES AND (B)(4) HAD THEM CYCLE POWER AND DISCONNECT. (B)(4) THEN ASSISTED WITH ENDING THERAPY AND REMOVING THE DISPOSABLE SET. PRODUCT SURVEILLANCE CONTACTED THE PATIENT WHO EXPLAINED SHE DID NOT KNOW WHAT MAY HAVE CAUSED THERE TO BE AIR IN THE PATIENT LINE. THE PATIENT STATED SHE PRIMED THE LINE COMPLETELY BEFORE CONNECTING. THE PATIENT STATED SHE WAS ABLE TO RESUME THERAPY SUCCESSFULLY WITH NEW SUPPLIES. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    CUSTOMER'S FIANCE REPORTED THAT ON (B)(6) 2010 CUSTOMER RECEIVED A RESULT OF 332 MG/DL ON HIS FREESTYLE LITE BLOOD GLUCOSE METER, WHICH WAS HIGHER THAN HE FELT. IT WAS FURTHER REPORTED HE SELF-ADMINISTERED "EXTRA" MEDICATION (GLIPIZIDE 25 MG, AN ORAL SULFONYLUREA MEDICATION) IN RESPONSE TO THIS READING AND SUBSEQUENTLY BEGAN TO FEEL "ILL". AT SOME POINT, THE CUSTOMER REPORTEDLY EXPERIENCED A LOSS OF CONSCIOUSNESS. PARAMEDICS WERE CALLED AND RECEIVED A BLOOD GLUCOSE RESULT, ON AN UNKNOWN BRAND OF METER, OF 142 MG/DL WITHIN 45 MINUTES AFTER THE RESULT THAT WAS OBTAINED ON THE ADC METER. CUSTOMER WAS TRANSPORTED TO A LOCAL HEALTHCARE FACILITY WHERE HE WAS DIAGNOSED WITH HYPOGLYCEMIA AND HYPERTENSION. CUSTOMER WAS TREATED WITH AN INTRAVENOUS INFUSION OF UNKNOWN TYPE IN ADDITION TO OTHER UNSPECIFIED ORAL MEDICATIONS. UPON DISCHARGE FROM THE HOSPITAL, THE CUSTOMER REPORTEDLY EXPERIENCED VERTIGO, LIGHTHEADEDNESS AND DIAPHORESIS. IT IS UNKNOWN AT THIS TIME IF THE CUSTOMER ATTEMPTED ANY SELF-TREATMENT FOR HIS SYMPTOMS. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1005433

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R