BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3790213 · Received May 5, 2014

    Report

    Report Number
    1823260-2014-03181
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 12, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CALLER REPORTED PATIENT RECEIVED AN UNEXPECTED ELEVATED BLOOD GLUCOSE LEVEL; READING WAS NOT PROVIDED. CALLER STATED PATIENT BECAME VERY TIRED AND DRY MOUTHED. CALLER REPORTED PATIENT INSERTED A NEW CARTRIDGE AND INFUSION SET; THERE WERE NO ERROR OR WARNING SIGNALS DISPLAYED ON THE INFUSION DEVICE. CALLER STATED AFTER THAT, PATIENT'S BLOOD GLUCOSE LEVEL BECAME HI AND SHE WAS TAKEN TO THE HOSPITAL AND ADMITTED. CALLER REPORTED PATIENT WAS TREATED WITH INSULIN VIA INFUSION. CALLER STATED PRACTITIONER AT THE HOSPITAL THINKS THE INFUSION DEVICE DID NOT GIVE INSULIN. NO FURTHER INFORMATION IS AVAILABLE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267227 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 073 YR Hospitalization| R UNKNOWN MEDICATION FOR HEART FAIURE| UNKNOWN MEDICATION FOR THYROID| UNKNOWN MEDICATION FOR BLOOD PRESSURE