FDA Adverse Event Injury Summary report: N

ONE TOUCH ULTRA

MDR report key: 510571 · Received February 3, 2004

Report

Report Number
2939301-2004-00741
Event Type
Injury
Date Received
February 3, 2004
Report Date
February 2, 2004
Manufacturer
LIFESCAN, INC.
Product Code
CFR
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
FL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

PATIENT CALLED BACK IN 02/2004 IN REGARDS TO THE LETTER THAT WAS SENT TO THE PATIENT IN REFERENCE TO THE CALL THAT PATIENT MADE BACK IN 12/2003. IN NOV 2003, DATE UNKNOWN, PATIENT WAS HALLUCINATING ALL DAY AND WAS FEELING WEAK AND THIRSTY. PATIENT TRIED TO TEST ON THE PATIENT METER AND WAS UNSUCCESFFUL. PATIENT THEN TOOK THE SET AMOUNT OF ORAL MEDICATION, METFORMIN (100MG A DAY). THE NEXT THING PATIENT KNEW THAT PATIENT WAS IN THE HOSP FOR ABOUT 3-4 DAYS. PATIENT WENT INTO A DIABETIC COMA AND A FAMILY MEMBER TOOK PATIENT TO THE HOSP AND THE PT'S BLOOD GLUCOSE WAS BETWEEN "500-600MG/DL". MD INCREASED PATIENT'S MEDICATION FROM ONE PILL TO TWO PILLS A DAY. THE DIAGNOSIS IN THE HOSP WAS HYPERGLYCEMIA. EVER SINCE PATIENT HAD THE METER REPLACED BY LFS, PATIENT HAS HAD AN ISSUE WITH THE METER AND WAS ALWAYS UNABLE TO OBTAIN A READING, BECAUSE METER WOULD PROMPT THE "APPLY SAMPLE" MESSAGE. AFTER THE INCIDENT, PATIENT SENT THE METER BACK WITHOUT CONTACTING LFS. PATIENT CALLED LFS IN DECEMBER, BECAUSE THE PATIENT'S MD WANTED PATIENT TO TEST THREE TIMES A DAY. CCR WAS UNABLE TO TROBLESHOOT WITH PATIENT, SINCE PATIENT HAD ALREADY SENT THE METER BACK TO LFS PRIOR TO CONTACTING CUSTOMER SERVICE. THEREFORE, CO DOES NOT HAVE AN EVIDENCE OF A MALFUNCTION. NO INFORMATION ON THE TECHNIQUE OF APPLYING BLOOD ON THE STRIP, SINCE PATIENT DOES NOT HAVE THE METER. A COMMON REASON FOR INSERT STRIP MESSAGE IS INACCURATE APPLICATION OF BLOOD TO THE TEST STRIP. BASED ON THE INFO PROVIDED, THIS CASE IS BEING REPORTED AS AN ADVERSE EVENT, WHICH COULD HAVE BEEN DUE TO USE ERROR OR MALFUNCTION.

Devices

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

Patients

Seq Age Sex Outcome Treatment
1 84 YR Hospitalization| L