FDA Adverse Event Malfunction Summary report: N

CLINISTIX

MDR report key: 280702 · Received May 25, 2000

Report

Report Number
MW4002786
Event Type
Malfunction
Date Received
May 25, 2000
Report Date
May 13, 2000
Manufacturer
BAYER CORP.
Product Code
JIL
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MD, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ACCORDING TO RPTR, THE CO MARKETS TWO VERSIONS OF ITS STRIPS, ONE CALLED CLINISTIX AND THE OTHER DIASTIX, THAT ARE SOLD WITH VIRTUALLY IDENTICAL LABELS EXCEPT FOR THE AMOUNT CONTAINED IN THE PACKAGE AND THE CODE NUMBER USED BY THE CO FOR IDENTIFICATION. ONE PACKAGE CONTAINS 50 STRIPS WHILE THE OTHER 100. IN RPTR'S PERSON AT "PRE DIABETIC" USE OF THE PRODUCT RPTR HAD BELATEDLY, AND QUITE BY ACCIDENT, FOUND THAT WHILE ONE WOULD INDICATE, FOR THE SAME SAMPLE, THE PRESENCE OF AN EXCESSIVE AMOUNT OF SUGAR IN THE URINE, THE OTHER WOULD SHOW NORMAL RESULTS. A FACT THAT COULD HAVE CONCEIVABLY CAUSED RPTR IRREPARABLE HARM. RPTR FEELS THESE STRIPS, CAPABLE OF SHOWING FALSE NEGATIVES, ARE A DEFINITE THREAT TO THE PUBLIC AND SHOULD BE IMMEDIATELY REMOVED FROM THE MARKETPLACE BEFORE THEY FOOL ANOTHER PT. A LONG-TIME FRIEND DIED RECENTLY FROM A SEVERE CASE OF DIABETES, WHICH TOWARD THE END CAUSED THEM TO URINATE EVERY 15 MINS OR SO, DESPITE THE FACT THAT THEY HAD SOME OF THE BEST HEALTH PLANS AVAILABLE. WHILE RPTR COULD NOT SAY, WHETHER THEIR FRIEND WAS SPECIFICALLY USING THE WRONG BAYER STRIP, OR WHETHER THE WRONG STRIP COULD HAVE BEEN A CONTRIBUTING FACTOR, RPTR WOULD NOT RULE IT OUT, HAVING THEMSELF BEEN VICTIM OF A FRIGHTENING EXPERIENCE WITH USE OF THE STRIPS. TO RPTR IT IS QUITE UNFATHOMABLE TO THINK THAT THESE IDENTICAL LABELS ON QUITE DIFFERENT PRODUCTS, FROM THE SAME CO, WERE ALLOWED TO COEXIST IN THE FIRST PLACE. RPTR WOULD STRONGLY SUGGEST THAT THEY BE THOROUGHLY TESTED AND CHANGES INITIATED BEFORE DIABETICS OR "PRE DIABETICS" WHO COUNT ON THEM ARE FOOLED INTO AN EARLY GRAVE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CLINISTIX URINE GLUCOSE TEST STRIP JIL BAYER CORP. NI NI
2 DIASTIX URINE GLUCOSE TEST STRIP JIL BAYER CORP. NI NI

Patients

Seq Age Sex Outcome Treatment
1 NO INFO