CHEMSTRIP® 10 UA
Received May 4, 2012 · Event occurred Apr 2, 2012
Report 1823260-2012-02408 · MDR key 2560219
Device
Generic name
Method, Enzymatic, Glucose (urinary, Non-quantitative)
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11895354160
Lot number
20835301
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
069 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE USER RECEIVED QUESTIONABLE URINALYSIS RESULTS FOR ONE PATIENT SAMPLE FROM THE URISYS 1100 ANALYZER SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, THE RESULT FOR LEUKOCYTES WAS DISCREPANT. THE INITIAL RESULT WAS "NEGATIVE" FOR LEUKOCYTES. THE RESULT FROM THE CRITERION II METER FOR LEUKOCYTES IS 100 WBC/UL. THE CALLER DID A MICROSCOPIC CONFIRMATORY TEST WHICH SHOWED 0-2 WBC/HPF FOR LEUKOCYTES. NO INFORMATION WAS PROVIDED TO DETERMINE IF THE ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE CALLER DOES NOT HAVE ANY SPECIFIC PATIENT INFORMATION. NO ACTIONS WERE REPORTED TAKEN BASED ON EITHER TEST.
Additional Manufacturer Narrative
THE STRIPS WERE NOT RETURNED.
Additional Manufacturer Narrative
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.