CHEMSTRIP ® 10 UA
Received Nov 30, 2021 · Event occurred Nov 4, 2021
Report 1823260-2021-03533 · MDR key 12897543
Device
Generic name
Method, Enzymatic, Glucose (urinary, Non-quantitative)
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11895354160
Lot number
51475511
Product problems
- False Negative Result
- False Negative Result
Patient
84 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO PRODUCT WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE TEST STRIPS WERE REQUESTED FOR INVESTIGATION. THE RETENTION MATERIAL OF LOT 51475500 WAS VISUALLY CHECKED AND QC DOCUMENTATION WAS CHECKED. THE RETENTION MATERIAL SHOWED NO ABNORMALITIES AND FULFILL THE REQUIREMENTS. QC DOCUMENTATION SHOWED NO ABNORMALITIES.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED A QUESTIONABLE LEUKOCYTES RESULT FOR ONE PATIENT URINE SAMPLE WITH A URISYS 1100 URINE ANALYZER SERIAL NUMBER (B)(4). THE LEUKOCYTE RESULT FROM THE METER WAS NEGATIVE. THE PATIENT SAMPLE WAS SENT FOR A LABORATORY CULTURE THAT REPORTED >100,000 E. COLI. NO URINALYSIS DIPSTICK TEST WAS PERFORMED AT THE LABORATORY. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.