CHEMSTRIP ® 10 MD
Received Jan 11, 2019 · Event occurred Dec 21, 2018
Report 1823260-2019-00160 · MDR key 8239730
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
NACatalog number
03260763160
Lot number
32223101
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER PROVIDED TEST STRIPS SHOWED SIGNS OF DISCOLORATION OF THE NITRITE, GLUCOSE, PROTEIN, AND KETONE TEST PADS. THE TEST STRIP CONTAINER PASSED THE TIGHTNESS TEST. THE RETENTION MATERIAL LOT NUMBER 32223100 SHOWS NO SIGN OF DISCOLORATION AND FULFILLS THE REQUIREMENTS. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THE CUSTOMER COMPLAINED OF FALSE POSITIVE NITRITE RESULTS FOR 85 PATIENT URINE "SAMPLE" TESTED WITH CHEMSTRIP 10 MD URINE TEST STRIPS ON A URISYS 1100 URINE ANALYZER SERIAL NUMBER (B)(4) COMPARED TO ANOTHER LABORATORY METHOD. THE SPECIFIC LABORATORY RESULTS AND LABORATORY METHOD WERE NOT PROVIDED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER STATED THAT THE QC WAS ACCEPTABLE. THE CUSTOMER MATERIAL OF LOT 32223100 WAS CHECKED WITH NATIVE URINE, A NITRITE DILUTION SERIES, AND A KETONES DILUTION SERIES. THE RESULTS OF THE MEASUREMENTS FULFILL OUR REQUIREMENTS. NO FALSE POSITIVE RESULTS WERE OBSERVED. THE INITIAL INVESTIGATION DETERMINED THAT AN ISSUE WITH THE METER WAS NOT SUSPECTED BASED ON THE ACCEPTABLE QC.