COMBUR 10 TEST
Received Jul 27, 2015 · Event occurred Jul 2, 2015
Report 1823260-2015-03866 · MDR key 4943173
Device
Generic name
Blood, Occult, Colorimetric, In Urine
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04510062171
Lot number
22933001
Product problems
- False Negative Result
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ALL TEST STRIP SPECIFICATIONS HAVE BEEN MET FOR THE RETENTION SAMPLES TESTED. THE CUSTOMER HAS NOT MADE ANY FURTHER COMPLAINTS ABOUT THE STRIP LOT USED.
Description of Event or Problem
THE CUSTOMER COMPLAINED OF FALSE NEGATIVE ERYTHROCYTES (ERY) RESULTS FOR AN UNKNOWN NUMBER OF PATIENTS WHEN TESTED WITH "STUDY" COMBUR-10 URINE TEST STRIPS. THE CUSTOMER IS COMPARING THE COMBUR-10 URINE STRIPS TO SIEMENS MULTISTIX WHICH ARE TESTED ON THE SIEMENS CLINITEK 50 INSTRUMENT. THE ACTUAL RESULTS HAVE NOT BEEN PROVIDED. THIS INFORMATION HAS BEEN REQUESTED. THE DATE OF EVENT IS NOT KNOWN. IT IS NOT KNOWN IF THE RESULTS ARE BEING USED FOR DIAGNOSTIC PURPOSES. THIS INFORMATION HAS BEEN REQUESTED. IT IS NOT KNOWN IF ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. IT IS NOT KNOWN IF AN ADVERSE EVENT OCCURRED. NO ADVERSE EVENT WAS REPORTED. WHILE THE COMBUR-10 URINE STRIPS ARE NOT SOLD IN THE US, THE ROCHE URINE CHEMSTRIP IS SIMILAR. RETENTION SAMPLES OF THE SAME LOT THAT THE CUSTOMER USED WERE TESTED. THE REACTION COLORS WERE ACCEPTABLE AND DID NOT SHOW ANY ABNORMALITIES. NO FALSE NEGATIVE RESULTS WERE OBSERVED.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).