BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 4142492 · Received October 6, 2014

    Report

    Report Number
    2939301-2014-26463
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 24, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (10/16/2014), THE PATIENT¿S METER HAS BEEN RETURNED ON 10/2/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 10/7/2014 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A DEFECTIVE CRYSTAL X1. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT THEIR ONETOUCH ULTRALINK METER WOULD NOT TURN ON AND WOULD NOT COMMUNICATE WITH THEIR MEDTRONIC INSULIN PUMP. THE CUSTOMER SERVICE REPRESENTATIVE (CSR) SPOKE WITH THE REPORTER ON (B)(4) 2014 WITH FOLLOW UP QUESTIONS FROM MEDICAL SURVEILLANCE AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT ALLEGED THAT THE PRODUCT ISSUE BEGAN ON AT 7:30AM ON (B)(6) 2014. THE PATIENT TESTS THEIR BLOOD GLUCOSE FOUR TIMES A DAY AND MANAGES THEIR DIABETES WITH INSULIN ON A SLIDING SCALE. THE PATIENT REPORTED NOT BEING ABLE TO TEST ON THE SUBJECT METER AND SUBSEQUENTLY DEVELOPED SYMPTOMS OF ¿DIZZINESS, FELL IN BATHROOM, SHAKING, COULDN¿T STAND, FELL UNCONSCIOUS, BLURRY/DARK VISION AND LIGHT STROKE¿. THE PATIENT¿S NURSE CALLED AN AMBULANCE AND THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM AND LATER ADMITTED TO HOSPITAL. THE PATIENT REPORTED BLOOD GLUCOSE READINGS OF ¿975MG/DL¿ AT 10:45AM, ¿975MG/DL¿ AT 11:00AM, ¿925MG/DL¿ BETWEEN 11:00 AND 11:50AM, ¿750MG/DL¿ AT 11:50 AND ¿700MG/DL¿ AT 2:00PM, ALL OBTAINED ON EMERGENCY SERVICE AND HOSPITAL METERS. THE PATIENT REPORTED BEING TREATED WITH INSULIN AND IV FLUIDS BUT WAS UNSURE OF THE TIME AND DOSE OF TREATMENT. THE PATIENT REPORTED STAYING IN HOSPITAL FOR TWO WEEKS AND REPORTED THEIR DIAGNOSIS AS ¿VERY HIGH BLOOD SUGAR AND LIGHT STROKE¿ BY A CARDIOLOGIST. PRIOR TO DEVELOPING THESE SYMPTOMS THE PATIENT REPORTED TESTING THEIR BLOOD SUGAR THE NIGHT BEFORE THE INCIDENT AND REPORTED THAT IT WAS WITHIN THEIR NORMAL RANGE. THE PATIENT ALSO REPORTED HAVING A COMMUNICATION ISSUE BETWEEN THE SUBJECT METER AND HIS MEDTRONIC INSULIN PUMP BUT IT WAS UNCLEAR WHEN THIS ISSUE BEGAN AND WHETHER IT WAS A DIRECT CONSEQUENCE OF THE POWER ISSUE. AT THE TIME OF TROUBLESHOOTING THE CSR VERIFIED THAT THERE WAS NO MISUSE OF THE PRODUCT AND THAT THE BATTERIES DID NOT NEED TO BE REPLACED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT SUFFERED A SERIOUS INJURY DUE TO HYPERGLYCEMIA AND WAS ADMITTED TO HOSPITAL AFTER THE REPORTED POWER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623662 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3646973

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R