BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 1820290 · Received August 30, 2010

    Report

    Report Number
    2939301-2010-07274
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 17, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE A LOW/DEAD BATTERY. 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

    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

    THE ACCOUNT REPORTED THE MULTIFOCAL INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITH A MONOFOCAL IOL 4 MONTHS AFTER INITIAL IMPLANT. THE REASON STATED WAS THE PATIENT'S UNHAPPINESS WITH HER VISION. IT WAS REPORTED THERE WAS NO PATIENT INJURY OR SURGICAL COMPLICATIONS.

    Description of Event or Problem · 1

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CLASSIFIED THIS COMPLAINT BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE LAY USER/REPORTER CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6) 2010 ALLEGING THAT THE ONETOUCH SELECT METER HAS A BATTERY INDICATOR ISSUE. THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATION AND HUMALOG INSULIN. THE BATTERY INDICATOR ISSUE BEGAN 2 MONTHS AGO PRIOR TO CONTACTING LFS. THE BATTERY WAS PROMPTLY REPLACED. THE PATIENT REPORTEDLY WAS ABLE TO TEST HIS BLOOD GLUCOSE AS USUAL. DURING THAT TIME, THE REPORTER CLAIMED THAT THE PATIENT HAD HAS LOW BLOOD SUGAR SYMPTOM DESCRIBED AS "SWEATY" WHILE OBTAINING A BLOOD GLUCOSE READING OF "40 MG/DL" ON THE SUBJECT METER. SELF-TREATMENT WITH GLUCOSE TABLET WAS GIVEN TO THE PATIENT AT THE TIME OF CONCERN. ON (B)(6) 2010, THE SUBJECT METER PROMPTED WITH THE BATTERY INDICATOR MESSAGE AGAIN. THE PATIENT TOOK HIS USUAL 805 MG OF METFORMIN, 65 UNITS OF HUMALOG IN THE MORNING, AND 40 UNITS OF HUMALOG AT NIGHT ON THE DAY OF CONCERN. REPORTEDLY, SOMETIME AFTER THE BATTERY INDICATOR ISSUE STARTED THAT DAY, THE PATIENT DEVELOPED SYMPTOM OF SWEATY. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE POWER ISSUE WAS NOT RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY HAD SYMPTOM THAT CAN BE ASSOCIATED WITH HYPOGLYCEMIA AFTER THE BATTERY INDICATOR ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3009341

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening