CHEMSTRIP 10 UA
Received May 3, 2011 · Event occurred Apr 8, 2011
Report 1823260-2011-02349 · MDR key 2074923
Device
Generic name
Method, Enzymatic, Glucose (urinary, Non-quantitative)
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11895354160
Lot number
20031104
Product problems
- False Negative Result
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Additional Manufacturer Narrative
THE RESULTS OF THE INVESTIGATION WITH THE USER'S DEVICE SHOWED THAT THE VALUES WERE SLIGHTLY LOWER IN COMPARISON TO A REFERENCE METHOD. HOWEVER, THE DIFFERENCE WAS NOT POTENTIALLY CRITICAL AND WAS NOT A RISK FOR THE USER OR THE PATIENT. THE SUSPECT TRAY WAS NOT AVAILABLE FOR INVESTIGATION, THEREFORE, NO SPECIFIC ROOT CAUSE COULD BE DETERMINED. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE ISSUE.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER STATING THE ASSAY INVOLVED WAS LEUKOCYTES, NOT ERYTHROCYTES AS PREVIOUSLY REPORTED ON THE INITIAL MEDWATCH. THE REPEAT RESULT ON A "CUA" WAS "++" WHICH THE USER STATED EQUALS 500 LEU/UL. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN WHO ORDERED TESTING IN THE LABORATORY TO CONFIRM THE NEGATIVE RESULT.
Description of Event or Problem
THE USER RECEIVED A QUESTIONABLE ERYTHROCYTE RESULT FOR ONE PATIENT URINE SAMPLE FROM THE URISYS 1100 URINE ANALYZER (B)(4). THE INITIAL RESULT WAS NEGATIVE. THE RESULT FROM THE LABORATORY ON A "CUA" WITH THE SAME LOT NUMBER OF CHEMSTRIPS WAS "++" AND A VISUAL READING OF THE CHEMSTRIP WAS ALSO POSITIVE. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE ISSUE. THE USER STATED SHE THOUGHT THE ISSUE MAY HAVE BEEN CAUSED BY THE TRAY ON THE ANALYZER.