FDA Adverse Event Malfunction Summary report: N

FASTTAKE

MDR report key: 465223 · Received June 6, 2003

Report

Report Number
2939301-2003-03803
Event Type
Malfunction
Date Received
June 6, 2003
Report Date
May 25, 2003
Manufacturer
LIFESCAN, INC.
Product Code
CFR
Removal / Correction Number
NA
Product Problem
Yes
Report Source
Manufacturer report
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

PT CALLED LFS ALLEGING THAT THEIR METER WAS READING INACCURATELY LOW. PT REPORTED FEELING TIRED AND EXPERIENCING PERSPIRATION. PT OBTAINED A "98 MG/DL", "97 MG/DL" AT THE TIME OF CONCERN. THE PT DID NOT PROVIDE THE TIME OF THE TESTS. AT 1:45 AM THE PT OBTAINED A "94 MG/DL" AND ASKED THEIR FRIEND TO TEST PT ON THEIR METER. PT'S FRIEND OBTAINED A "398 MG/DL" ON THEIR METER. THE PT THEN DECIDED TO TAKE "24 UNITS" OF INSULIN. PT REPORTED FEELING WELL FOLLOWING THE INSULIN INJECTION. A RESULT OF "14 MG/DL" WAS OBTAINED USING THE REPORTED TEST STRIPS AND A "101 MG/DL" WAS OBTAINED USING A NEW VIAL OF TEST STRIPS. THE CUSTOMER SERVICE REP WALKED PT THROUGH TWO CONTROL SOLUTION TESTS, WHICH FELL BELOW THE ACCEPTED RANGE (127& & 132/135-198 MG/DL). A CONTROL SOLUTION TEST USING THE NEW VIAL OF STRIPS FELL WITHIN THE ACCEPTED RANGE (152/122-179 MG/DL). THE CUSTOMER SERVICE REP ATTEMPTED TO CALL THE PT BACK TO OBTAIN ADDITIONAL INFO, HOWEVER, THERE WAS NO ANSWER. IT WOULD HAVE BEEN HELPFUL KNOWING WHEN THE PT FIRST OBTAINED THE "98, 97 AND 93 MG/DL", WHEN THE SYMPTOMS BEGAN, WHEN THE "14 MG/DL" AND "101 MG/DL" READINGS WERE OBTAINED, AND PT'S MEDICATION RGIMEN. THERE WAS NO EVIDENCE THAT THE PT SOUGHT ANY MEDICAL CARE FROM A HEALTH CARE PROFESSIONAL. THERE WAS NO EVIDENCE THAT THE METER CONTRIBUTED TO A SERIOUS INJURY, SINCE THE PT SUFFERED THE SYMPTOMS PRIOR TO TESTING. THE PT TOOK INSULIN BASED ON THEIR FRIEND'S METER. PT DID NOT ADMINISTER ANY SELF-TREATMENT BASED ON THE REPORTED METER; HENCE THE METER/STRIPS DID NOT CONTRIBUTE TO ANY ADVERSE EVENT. THE COMPARISON BETWEEN THE REPORTED METER AND THE FRIEND'S METER IS INVALID, HOWEVER, DUE TO THE SIGNIFICANT DIFFERENCE AND TWO FAILED CONTROL SOLUTION TESTS, THE TEST STRIPS MAY HAVE BEEN READING INACCURATELY LOW. THERE WAS NO EVIDENCE OF A METER MALFUNCTION, HOWEVER, THE TEST STRIPS ARE BEING REPORTED DUE TO EVIDENCE LEADING TO A POSSIBLE STRIP MALFUNCTION. THE CUSTOMER SERVICE REP REPLACED THE TEST STRIPS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 FASTTAKE BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA 1018296

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN