BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBAS P (701) POST ANALYTICAL UNIT

    MDR report key: 3790085 · Received May 5, 2014

    Report

    Report Number
    1823260-2014-03174
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 8, 2014
    Report Date
    July 28, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED ABOUT THE CUSTOMER INJURY. THE CUSTOMER WAS HAVING SOME PAIN IN THE WEB AREA OF THE FIRST FINGER AND HIS THUMB. IT WAS CONFIRMED THERE WAS NO TENDON OR LIGAMENT DAMAGE. THE CUSTOMER WAS NOT ON ANY MEDICATION. THE CUSTOMER IS SCHEDULED FOR AN MRI TO CHECK FOR ANY FRACTURES TO HIS HAND AND WILL BE REEVALUATED BY THE HAND SPECIALIST REGARDING MRI RESULTS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ABOUT THE EVENT. THE CUSTOMER HAD HIS FINGERS UNDER THE TRAY DRAWERS AS HE SLIDE THE TRAY IN. HIS FINGERS HIT THE EDGE OF THE INSTRUMENT AND HIS FINGERS WERE CUT OR BADLY SCRAPED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED AN OPERATOR HANDLING ERROR WAS THE MOST LIKELY CAUSE OF THE EVENT. HANDLES WERE IMPLEMENTED ON THE DRAWERS TO MINIMIZE INADVERTENT TOUCHING OF MOVING PARTS. OTHER MEASURES SUCH AS THE ROUNDED EDGES AND DISTANCE BETWEEN THE TRAY DRAWER AND FLAP WERE IMPLEMENTED TO MINIMIZE THE RISK OF INJURY IN THE EVENT OF IMPROPER USE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED ABOUT THE CUSTOMER INJURY. THE CUSTOMER'S MRI WAS NORMAL. THE CUSTOMER VISITED THE HAND SPECIALIST ON (B)(6) 2014 AND WAS RELEASED TO GO BACK TO WORK ON (B)(6) 2014 AND TO PERFORM HIS NORMAL DUTIES.

    Description of Event or Problem · 1

    THE FIELD SERVICE REPRESENTATIVE REPORTED THE CUSTOMER INJURED HIS LEFT HAND WHILE REPLACING THE RACK INPUT TRAY ON THE ANALYZER. THE CUSTOMER STATED HE WAS PULLING OUT A TRAY WHICH CAME OFF THE TRACK AND HE ACCIDENTALLY GOT HIS LEFT HAND GOT CAUGHT BETWEEN THE FOLD OUT DOOR AND THE TRAY. THE CUSTOMER STATED THERE WAS NOTHING WRONG WITH THE SYSTEM. THE CUSTOMER VISITED (B)(6) (WORKERS COMPENSATION) AND THEY DIRECTED HIM TO A HAND DOCTOR. HIS HAND WAS IMMOBILIZED IN A CAST, BUT HE CONFIRMED NOTHING WAS BROKEN AND HIS SKIN WAS NOT PUNCTURED. HE RECEIVED NO MEDICATIONS. THE CUSTOMER WAS INSTRUCTED TO STAY HOME FROM WORK AS HE WAS ONLY ABLE TO DO PAPERWORK SINCE THE CAST WAS TOO BIG FOR HIS GLOVES TO FIT. THE CUSTOMER'S SUPERVISOR STATED SHE BELIEVED THE CUSTOMER WAS DOING PHYSICAL THERAPY, BUT WAS UNSURE. ADDITIONAL INFORMATION CONCERNING THE CUSTOMER'S CONDITION AND TREATMENT WAS REQUESTED, BUT WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. HE CHECKED THE OPERATION OF THE DOOR AND RACK SLIDER AND FOUND THEY WERE FUNCTIONING PROPERLY. HE VERIFIED THE ANALYZER WAS FUNCTIONING WITHOUT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268706 COBAS P (701) POST ANALYTICAL UNIT AUTOMATED POST ANALYTICAL SYSTEM JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IBUPROFEN