CHEMSTRIP ® 10 MD
Received Dec 11, 2018 · Event occurred Nov 21, 2018
Report 1823260-2018-04750 · MDR key 8150041
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
NACatalog number
03260763160
Lot number
32223101
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER MATERIAL HAS BEEN VISUALLY CHECKED AND SHOWED NO ABNORMALITIES OR SIGNS OF DISCOLORATION. THE CUSTOMER MATERIAL OF LOT 32223101 WAS MEASURED ON AN IU URISYS 1100 WITH NATIVE URINE AND A NITRITE DILUTION SERIES. THE RESULTS OF THE MEASUREMENTS FULFILL THE REQUIREMENTS. NO FALSE POSITIVE RESULTS WERE OBSERVED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THE CUSTOMER RECEIVED A QUESTIONABLE NITRATE RESULT FOR ONE PATIENT URINE SAMPLE FROM URISYS 1100 ANALYZER SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS POSITIVE FOR NITRATE. THE SAMPLE WAS SENT TO THE HOSPITAL LABORATORY AND THE RESULT WAS NEGATIVE. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. REPLACEMENT PRODUCT WAS SENT. THE RETENTION MATERIAL OF LOT #32223100 WAS MEASURED ON AN IU URISYS 1100 WITH NATIVE URINE AND A NITRITE-DILUTION-SERIES. THE RESULTS OF THE MEASUREMENTS FULFILL THE REQUIREMENTS. NO FALSE POSITIVE RESULTS WERE OBSERVED.