BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBAS® GLU TEST STRIPS

    MDR report key: 24833524 · Received April 9, 2026

    Report

    Report Number
    1823260-2026-01369
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    March 15, 2026
    Report Date
    May 6, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    PZI
    PMA / PMN Number
    K220272
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TEST STRIP LOT NUMBER WAS NOT PROVIDED. THE DEVICE WAS REQUESTED FOR INVESTIGATION.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION THAT THE COBAS® PULSE MAY HAVE CONTRIBUTED TO A DELAY IN TREATMENT, ALLEGEDLY CAUSING POSSIBLE HARM TO THE PATIENT. THE REPORTER STATED THAT DURING NEONATAL GLYCEMIC MONITORING, IT WAS NOT POSSIBLE FOR THEM TO RECORD A VALUE OR DRAW BLOOD USING THE POINT-OF-CARE COBAS® PULSE DEVICE. THE NEONATE PATIENT REPORTEDLY HAD TO BE PRICKED THREE TIMES, AND MORE THAN FIFTEEN TEST STRIPS HAD TO BE USED UNTIL THE DEVICE COULD REGISTER A VALUE. REPORTEDLY, EACH TIME, AN ERROR MESSAGE APPEARED. THE SPECIFIC ERROR WAS NOT PROVIDED. THE REPORTER ALLEGED THAT THEY HAD TO USE ANOTHER DEVICE FROM THE NEONATOLOGY DEPARTMENT TO OBTAIN A RESULT. THE REPORTER ALLEGED THAT 45 MINUTES PASSED BEFORE THEY OBTAINED A CORRECT RESULT. ALLEGEDLY, THE NEONATE PATIENT TURNED OUT TO HAVE HYPOGLYCEMIA WITH A METER RESULT OF 29 MG/DL AND ALLEGEDLY NEEDED MEDICAL ATTENTION. THE REPORTER ALLEGED THAT THEIR COLLEAGUES HAD EXPERIENCED THE SAME PROBLEM TWICE IN THE MATERNITY WARD, WHERE, REPORTEDLY, SIX TEST STRIPS WERE USED ON THE SAME NEONATE PATIENT (THERE WAS NO REPORT OF HARM TO THIS PATIENT). FURTHER CLARIFICATION REGARDING THE EVENT HAS BEEN REQUESTED, BUT HAS NOT BEEN PROVIDED: WHAT ERRORS WERE OBTAINED FROM THE DEVICE WHILE THE CUSTOMER WAS ATTEMPTING TO GET MEASUREMENTS? WAS THE NEONATE ADMITTED TO THE NEONATAL INTENSIVE CARE UNIT (NICU)? WHAT WAS THE NEONATE BEING TREATED FOR? WHAT ARE THE NEONATE PATIENT'S COMORBIDITIES? WHAT DIAGNOSES DID THE NEONATE PATIENT HAVE? DID THE NEONATE PATIENT HAVE ANY CONSEQUENCES AND TREATMENT FOR NOT HAVING THE RESULT FOR 45 MINUTES AND BEING HYPOGLYCEMIC FOR 45 MINUTES?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238059 COBAS® GLU TEST STRIPS PRESCRIPTION USE BLOOD GLUCOSE METER FOR NEAR-PATIENT TESTING PZI ROCHE DIAGNOSTICS 803064

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Life Threatening| O