BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 1790961 · Received August 10, 2010

    Report

    Report Number
    2939301-2010-06387
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 6, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    (B)(4). THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6), 2010 THE LAY USER/PATIENT IN THE (B)(4) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VITA METER WAS GIVING INACCURATELY HIGH READINGS. ON (B)(6), 2010 THE TECHNICAL SERVICE REPRESENTATIVE (TSR) SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION. SINCE (B)(6) 2010 THE PATIENT CLAIMED THE BLOOD GLUCOSE READINGS OBTAINED ON THE REPORTED METER WERE HIGH COMPARED TO HER EXPECTED VALUES, AND COMPARED TO HER BACKUP METER, WHICH WAS A WHOLE BLOOD-CALIBRATED METER. THE PATIENT WAS UNAWARE OF THE DIFFERENCE BETWEEN PLASMA- AND WHOLE BLOOD-CALIBRATED METER READINGS. ON (B)(6), 2010, TWO HOURS POST-LUNCH, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 23.0 MMOL/L ON THE REPORTED METER. BASED ON THIS READING, THE PATIENT TOOK AN INCREASED DOSE OF NOVORAPID INSULIN, ELEVEN UNITS INSTEAD OF EIGHT. AFTERWARDS, THE PATIENT EXPERIENCED HER SYMPTOMS OF HYPOGLYCEMIA: "INABILITY TO CONTROL HER VISION", WEAKNESS AND LACK OF ENERGY. WHILE SYMPTOMATIC, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 16.1 MMOL/L ON THE REPORTED METER, AND A READING OF 4.4 MMOL/L (PLASMA-EQUIVALENT) ON THE BACKUP METER. THE PATIENT ADMINISTERED SELF-TREATMENT WITH APPLE JUICE; SHE DID NOT SEEK ANY MEDICAL ATTENTION. THE PATIENT TAKES LANTUS INSULIN AND NOVORAPID INSULIN ON A SLIDING SCALE. HER EXPECTED BLOOD GLUCOSE READINGS RANGE FROM 9.0 MMOL/L TO 13.0 MMOL/L. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING AN INCREASED DOSE OF INSULIN BASED ON AN ELEVATED METER READING, AND RECEIVED TREATMENT WITH FOOD TO ALLEVIATE THOSE SYMPTOMS. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP REBOOTED WITHOUT USER INTERVENTION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ADD'L INFO WAS RECEIVED 10/05/2010. IT WAS REPORTED THAT THE PT WHO HAD CORONARY BYPASS SURGERY RETURNED TO THE OPERATING ROOM AFTER SEVERAL HOURS FOR BLEEDING, WHERE IT WAS DISCOVERED, THE CLIP HAD SLIPPED OFF THE SAPHENOUS VEIN GRAFT IN THE HEART. THE REPORTER STATED THE PT SUFFERED A NEUROLOGICAL DEFICIT POST OPERATIVELY. THE PT'S CURRENT CONDITION IS UNK.

    Devices

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

    Patients

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