FDA Adverse Event Injury Summary report: N

ONE TOUCH PROFILE

MDR report key: 631096 · Received August 26, 2005

Report

Report Number
2939301-2005-03747
Event Type
Injury
Date Received
August 26, 2005
Date of Event
August 13, 2005
Report Date
August 19, 2005
Manufacturer
LIFESCAN, INC.
Product Code
CFR
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
NY, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

THE PT CALLED LIFESCAN (LFS) IN 05 AND ALLEGED THAT THEIR METER WAS READING INACCURATELY LOW. THE MEDICAL AFFAIRS SPECIALIST SPOKE TO THE PT ON THE 3RD DAY AND OBTAINED/VERIFIED THE FOLLOWING INFORMATION. ABOUT A WEEK AGO THE PT WAS NOT FEELING WELL; THEY WERE VOMITING AND FELT ILL. THEY TESTED ON THEIR METER THROUGHT THE DAY AND OBTAINED RESULTS OF 243, 244, AND 180 MG/DL. IN THE AFTERNOON, APPROX 5:00 P.M., THEY TESTED AND OBTAINED A RESULT OF 200 MG/DL. THEY WERE FEELING VERY ILL AT THE TIME OF THE RESULT, SO A FAMILY MEMBER DROVE THEM TO THE HOSPITAL WITHIN 10 MINUTES OF OBTAINING THE RESULT. THEIR BLOOD GLUCOSE WAS TESTED ON THE HOSPITAL METER AND THE RESULT WAS 500 MG/DL. THEY DID NOT TREAT THEMSELVES BEFORE GOING TO THE HOSPITAL BECAUSE THEY FELT SO ILL. THE PT TAKES INSULIN AND THEY REPORTED THAT THEY WOULD HAVE TAKEN MORE INSULIN THAT DAY HAD THEY KNOWN THAT THEIR BLOOD GLUCOSE LEVEL WAS HIGHER. THE PT WAS TREATED WITH INSULIN AND WAS ALSO TREATED FOR AN UNSPECIFIED INFECTION. THE PT WAS STILL NOT FEELING WELL AT THE TIME OF THE CALL AND IT WAS DIFFICULT TO OBTAIN INFORMATION REGARDING THE TIMES OF THE BLOOD GLUCOSE RESULTS AND THE AMOUNT OF MEDICATION TAKEN. THE TEST TRIPS WERE IN GOOD CONDITION, CODES MATCHED, AND THE TECHNIQUES FOR APPLYING THE BLOOD TO THE TEST STRIP AND FOR CLEANING THE PUNCTURE SITE WERE CORRECT. THE PT DID NOT HAVE ANY CONTROL SOLUTION TO TROUBLESHOOT. A REPLACEMENT METER HAS BEEN SENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ONE TOUCH PROFILE GLUCOSE MONITORING SYS/KIT CFR LIFESCAN, INC. NA 2514933

Patients

Seq Age Sex Outcome Treatment
1 63 YR Hospitalization| L| R