BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1163087 · Received September 15, 2008

    Report

    Report Number
    2939301-2008-02263
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 12, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STIRPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY/USER PT CONTACTED LFS ALLEGING INACCURATE READINGS USING ONE TOUCH TEST STRIP LOT# 2710382 COMPARED TO A NEW VIAL OF TEST STRIPS. A MEDICAL AFFAIRS SPECIALIST (MAS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFO: THE PT LIVES IN A HEALTH CENTER. IN 2008 AT 6:21 PM, THE PT TESTED HIS BLOOD GLUCOSE BEFORE DINNER AND REPORTEDLY OBTAINED A READING OF 200 MG/DL. BASED ON HIS DIABETES REGIMEN, HE TOOK 8 UNITS OF PROTAPHANE INSULIN, 18 UNITS OF PROTAPHANE FOR THE 9 UNITS OF CARBOHYDRATES HE INTENDED TO EAT FOR DINNER AND AN ADDITIONAL 2 UNITS OF PROTAPHANE FOR THE READING OF 200 MG/DL. HE ALSO TOOK 20 UNITS OF NOVORAPID INSULIN. HE ATE DINNER AND AT 8:29 PM, HE TESTED AND OBTAINED A READING OF 294 MG/DL. HE INJECTED 11 UNITS OF PROTAPHANE INSULIN AND NOW CLAIMS THAT HE ACCIDENTLY INJECTED TOO MUCH INSULIN, SINCE IT WAS NOT PART OF HIS REGIMEN. HE DID NOT REALIZE AT THE TIME OF TESTING, THAT HE HAD TAKEN TOO MUCH INSULIN (THE PT HAD TAKEN A TOTAL OF 28 UNITS OF PROTAPHANE INSULIN FROM 6:21 PM - 8:29 PM). AT 9:47 PM, HE TESTED HIS BLOOD GLUCOSE AGAIN AND OBTAINED A 249 MG/DL AND INJECTED 8 UNITS OF PROTAPHANE INSULIN BASED ON THE 249 MG/DL READING. AT 11:56 PM, THE PT TESTED HIS BLOOD GLUCOSE AND OBTAINED A 152 MG/DL. AT THE TIME OF TESTING, THE EXHIBITED SYMPTOMS, WHICH CONSISTED OF FEELING SWEATY AND JITTERY. HE THEN CONTACTED THE NIGHT NURSE WHO TESTED THE PT USING HER ONE TOUCH ULTRA METER AND OBTAINED A 46 MG/DL. THE PT THEN ATE 2 BANANAS AND FELT BETTER 15-30 MINUTES LATER. THE NURSE THEN GAVE HIM A NEW VIAL OF ONE TOUCH TEST STRIPS. ON THE NEXT DAY AT 12:09 AM, THE PT TESTED HIS BLOOD GLUCOSE ON THE NEW VIAL OF TEST STRIPS AND OBTAINED A 60 MG/DL AND THEN TESTED ON HIS OLD TEST STRIPS (LOT# 2710382) AND OBTAINED A 173 MG/DL. THE SUBJECT TEST STRIPS (LOT# 2710382) THAT THE PT HAD BEEN USING HAD EXPIRED IN AUGUST 2008. USING EXPIRED TEST STRIPS CAN LEAD TO FALSE BLOOD GLUCOSE READINGS. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIPS WAS CORRECT. THE PT DID NOT HAVE PRODUCTS WITH HIM AT THE TIME OF THE CALL TO RUN A QUALITY CONTROL TEST. PT TESTS HIS BLOOD GLUCOSE 4-5 TIMES A DAY. PATIENT'S BLOOD GLUCOSE IS VERY ERRATIC AND HE IS UNABLE TO PROVIDE WHAT IS CONSIDERED A "NORMAL" READING FOR HIM. ALTHOUGH THE PT CLAIMS THAT HE ACCIDENTLY TOOK TOO MUCH INSULIN, SINCE IT WAS NOT PART OF HIS REGIMEN, THE COMPLAINT IS BEING REPORTED SINCE THE PT TOOK INSULIN BASED ON THE METER READINGS, AND SUFFERED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA. THE PT HAD ALSO BEEN USING EXPIRED TEST STRIPS, WHICH CAN LEAD TO FALSE BLOOD GLUCOSE READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2710382

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening