BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 4081980 · Received September 11, 2014

    Report

    Report Number
    1823260-2014-06927
    Event Type
    Injury
    Date Received
    September 11, 2014
    Date of Event
    August 15, 2014
    Report Date
    July 20, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER REPORTED THAT DURING THE NIGHT AROUND 1:30 AM TODAY HE HAD AN EPISODE OF HYPOGLYCEMIA IN WHICH HE PASSED OUT AND WAS NON-COHERENT. HIS WIFE FORCE-FED HIM SOME MILK AND FOOD UNTIL HE CAME TO. THE PATIENT STATED HE THINKS HE DOUBLE DOSED ON INSULIN. THIS WAS CONFIRMED IN THE PUMP'S MEMORY BY THE AGENT. AGENT EXPLAINED HOW TO CHECK IF THE PUMP DELIVERED BOLUS. CALLER DIDN'T KNOW THAT WAS AN OPTION. PUMP IS WORKING AS INTENDED. NO PRODUCT REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560583 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 039 YR Required Intervention VERIO IQ GLUCOMETER| FISH OIL 1200 MG DAILY| ASPIRIN 81 MG