CHEMSTRIP ® 10 MD
Received Nov 14, 2018 · Event occurred Oct 19, 2018
Report 1823260-2018-04276 · MDR key 8071265
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
NACatalog number
03260763160
Lot number
25566401
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 LOT NUMBER THAT WAS INITIALLY PROVIDED WAS INCORRECT. MEDWATCH FIELD D4 WAS UPDATED.
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE RETENTION MATERIAL OF LOT 25566400 WAS MEASURED ON AN URISYS 1100 WITH NATIVE URINE AND A NITRITE DILUTION SERIES AND WAS VISUALLY CHECKED. THE RESULTS OF THE MEASUREMENTS FULFILL OUR REQUIREMENTS. NO FALSE POSITIVE RESULTS WERE OBSERVED.
Description of Event or Problem
THE RETENTION MATERIAL OF LOT #25566400 WAS MEASURED ON AN IU URISYS 1100 WITH 0-NATIVE URINE AND A NITRITE-DILUTION-SERIES AND WAS VISUALLY CHECKED. THE RESULTS OF THE MEASUREMENTS FULFILL OUR REQUIREMENTS. NO FALSE POSITIVE RESULTS WERE OBSERVED.
Description of Event or Problem
THE CUSTOMER COMPLAINED THEY WERE RECEIVING FALSE POSITIVE NITRITE RESULTS FOR PATIENT URINE SAMPLES FROM URISYS 1100 URINE ANALYZER SERIAL NUMBER (B)(4). THE DOCTORS REQUESTED THAT THE CUSTOMER START DOING VISUAL READS WHEN THE PATIENT'S NITRITES TESTED POSITIVE ON THE METER. AFTER A FEW METER AND VISUAL READS, THE VISUAL RESULTS WERE NEGATIVE BUT THE METER STILL PRODUCED POSITIVE RESULTS FOR NITRITES. THE NITRITE RESULTS WERE NEGATIVE WITH VISUAL TESTS AND BELIEVED TO BE CORRECT. THE CUSTOMER REPEATED THE TESTING MULTIPLE TIMES AND RECEIVED THE SAME RESULTS. THE CUSTOMER DOES NOT RUN QC. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION.