BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2233432 · Received September 2, 2011

    Report

    Report Number
    2939301-2011-08514
    Event Type
    Injury
    Date Received
    September 2, 2011
    Report Date
    August 16, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ((B)(6) 2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE METER WAS TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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. THE 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT'S WIFE CONTACTED LIFESCAN (LFS) ALLEGING THAT THE 'OK' BUTTON ON THE ONETOUCH ULTRALINK METER WAS NOT RESPONDING WHEN PRESSED. PER THE ONETOUCH ULTRALINK OWNER'S BOOKLET, THE 'OK' BUTTON IS USUALLY PRESSED TO TURN ON/OFF THE METER (TO ACCESS THE SETTINGS AND MEMORY) OR CONFIRM MENU SELECTIONS. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(4) 2011, AND OBTAINED THE FOLLOWING INFORMATION. THE REPORTER COULD NOT RECALL WHEN THE ALLEGED ISSUE FIRST OCCURRED BUT SHE STATED THAT THE 'OK' WOULD SOMETIMES RESPOND AND OTHER TIMES IT WOULD NOT. THE PATIENT REPORTED THAT THE PATIENT MANAGES HIS DIABETES WITH HUMALOG 100 INSULIN THROUGH PUMP THERAPY. THE REPORTER INFORMED THE MSS THAT ON AN UNKNOWN DATE AND TIME, WHEN THE PATIENT WAS PRESSING THE OK BUTTON, IT WOULD NOT RESPOND AND THEREFORE HE WAS NOT ABLE TO CHECK HIS BLOOD GLUCOSE. THE REPORTER STATED THAT THE PATIENT WAS ABLE TO TEST HIS BLOOD GLUCOSE USING THE SUBJECT METER TWO HOURS PRIOR TO WHEN THE ALLEGED ISSUE OCCURRED AND REPORTED THAT HIS BLOOD GLUCOSE WAS "NORMAL." THE REPORTER COULD NOT RECALL THE REASON FOR PRESSING THE 'OK' BUTTON AT THAT TIME AND COULD NOT RECALL HOW MUCH TIME ELAPSED WHILST TRYING TO GET THE SUBJECT METER TO WORK. THE REPORTER CLAIMED THAT WHILE SHE WAS ATTEMPTING THE TEST ON THE SUBJECT METER, THE PATIENT WAS EXPERIENCING SYMPTOMS OF A LACK OF OXYGEN, SWEATS, WEAKNESS, IMMOBILITY AND INABILITY TO CONTROL HIS BODY' WHICH BECAME MORE SEVERE AFTER THE ALLEGED ISSUE BEGAN. THE REPORTER STATED THAT SHE IMMEDIATELY TESTED HIM USING ANOTHER DEVICE (ACCU-CHECK) THAT SHE KEEPS CLOSE BY AND REPORTED A MESSAGE OF "LOW GLUCOSE." THE REPORTER COULD NOT RECALL THE TIME OF THE TEST WITH THE BACK UP METER, BUT MENTIONED SHE TESTED HIM IMMEDIATELY AFTER THE ISSUE OCCURRED WITH THE SUBJECT METER. THE REPORTER STATED SHE TREATED HIM WITH A GLUCAGON INJECTION IMMEDIATELY BUT DID NOT DISCONNECT THE PUMP FROM THE PATIENT. SHE STATED HE BEGAN TO FEEL BETTER AFTERWARDS BUT COULD NOT RECALL HOW LONG IT TOOK FOR HIS BLOOD GLUCOSE TO STABILIZE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE OK BUTTON DID NOT RESPOND WHEN PRESSED DURING TROUBLESHOOTING. THERE WAS NO INDICATION OF TRAUMA OR MISUSE TO THE PRODUCT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS THE PATIENT WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3150955

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R