BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 770098 · Received October 12, 2006

    Report

    Report Number
    2939301-2006-01426
    Event Type
    Injury
    Date Received
    October 12, 2006
    Date of Event
    September 24, 2006
    Report Date
    September 27, 2006
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER FOR EVALUATON, BUT HAS NOT YET RECEIVED IT. IF THE METER IS RETURNED, LIFESCAN WILL EVALUATE IT AND, IF THE METER DOES NOT PASS INSPECTION. LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY/PATIENT CALLED LIFESCAN (LFS) IN 2006, AND ALLEGED THAT HIS METER WAS READING INACCURATELY. THE LFS REPRESENTATIVE SPOKE WITH THE PATIENT AND OBTAINED THE FOLLOWING INFORMATION. THE MAS SENT QUESTIONS TO THE REPRESENTATIVE TO VERIFY THE INFORMATION AND OBTAIN FURTHER CLARIFICATION. THE PATIENT REPORTED THAT HE OBTAINED RESULTS OF 285, 208, 180, AND 193 MG/DL ON HIS METER. THE METER RESULTS WERE VERIFIED IN THE METER'S MEMORY AND THEY WERE ACTUALLY 249, 203, 231, 167, 197, 237, AND 170 MG/DL. THESE RESULTS WERE ALL OBTAINED IN 2006 AT DIFFERENT TIMES BETWEEN 8:29 A.M. TO 4:54 P.M. NONE OF THE RESULTS FAILED PRECISION TESTING. THE PATIENT STATED HE FELT "WEIRD" AT THE TIME OF THE HIGH RESULTS, BUT COULD NOT SPECIFY HIS SYMPTOMS. HE TOOK HIS INSULIN AS DIRECTED IN THE MORNING: LANTUS 24 UNITS AND HUMALOG 8 UNITS. ON THE DAY OF THE EVENT, SEPTEMBER 24, 2006. THE PATIENT TESTED HIS BLOOD GLUCOSE AND OBTAINED A METER RESULT OF 249 MG/DL. HE TOOK HIS LANTUS INSULIN AND 2 EXTRA UNITS OF HUMALOG BASED ON THE METER RESULT FOR A TOTAL OF 10 UNITS. HE ATE BREAD AND BUTTER AND A FEW CUPS OF COFFEE. HE LATER TOOK 5 UNITS OF INSULIN WITH LUNCH. THE PATIENT STATED THAT WHEN HE WOKE UP FEELING "VERY TIRED" THAT MORNING, BUT HE FELT "BAD" AROUND NOON. HIS COLLEAGUES TOOK HIM TO A CLINIC AROUND 12:15 P.M. THE PATIENT TESTED ON HIS METER WHEN HE FELT WORSE; THE RESULTS WAS 172 MG/DL. UPON ARRIVING AT THE HOSPITAL THE PATIENT PASSED OUT. HIS BLOOD GLUCOSE WAS TESTED ON A METER AND WITH THE LAB. HIS RESULTS WERE 27 MG/DL AND SOME TIME LATER A RESULT OF 75 MG/DL. IT IS NOT KNOWN WHICH RESULT WAS A METER RESULT AND WHICH WAS A LAB RESULT OR IF THERE TREATMENT GIVEN BETWEEN THE TWO RESULTS. THE PATIENT WAS ADMITTED WITH A DIAGNOSIS OF "SEVERE HYPOGLYCEMIA". THE TESTING TECHNIQUE WAS CORRECT AND THE TECHNIQUE FOR CLEANING THE PUNCTURE SITE WAS CORRECT. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TROUBLESHOOT. THIS COMPLAINT IS BEING REPORTED AS THE PATIENT BASED HIS INSULIN DOSAGE ON THE METER RESULT AND LATER WAS TREATED FOR HYPOGLYCEMIA; ADDITIONALLY, THE PATIENT'S SYMPTOMS DID NOT CORRELATE WITH THE PATIENT'S METER RESULT AT THE TIME OF THE EVENT. A REPLACEMENT METER HAS BEEN SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2607049

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| L| R