CHEMSTRIP 10 MD URINE TEST STRIPS
Received Feb 10, 2025 · Event occurred Jan 16, 2025
Report 1823260-2025-00386 · MDR key 21347047
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
D051188Catalog number
03260763160
Lot number
80097404
Product problems
- Incorrect Measurement
- Device Difficult to Setup or Prepare
- Incorrect Measurement
- Device Difficult to Setup or Prepare
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SECTIONS D1-D4, G1, AND G4 WERE UPDATED. THE RETENTION MATERIAL FOR LOT 80097400 WAS MEASURED ON AN IU URISYS 1100 ANALYZER EQUIPPED WITH SW-V. 6.71 AND BY VISUAL READING WITH 0-NATIVE-URINE AND A PROTEIN-DILUTION-SERIES ACCORDING TO TESTING-PLAN. THE TESTING SHOWED NO ABNORMAL RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Additional Manufacturer Narrative
THE URINE TEST STRIP LOT NUMBER IS 1080097404 WITH AN EXPIRATION DATE OF 30-NOV-2025. IT WAS REPORTED THE CUSTOMER RECEIVED AN E-5 ALARM DURING A CALIBRATION ISSUE. THE TEST STRIPS ARE NOT AVAILABLE FOR INVESTIGATION AS THEY HAVE BEEN DISCARDED. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE NEGATIVE PROTEIN RESULTS FOR APPROXIMATELY 6 PATIENT SAMPLES ON A URISYS 1100. IT WAS ALLEGED THAT THE VISUAL RESULTS WERE 2 COLOR BLOCKS OUT (POSITIVE).