COMBUR-9-TEST 50STR.
Received Nov 9, 2021 · Event occurred Oct 12, 2021
Report 1823260-2021-03284 · MDR key 12778042
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsModel number
COMBUR 9Catalog number
04510038191
Lot number
52422101
Product problems
- False Negative Result
- False Negative Result
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE TEST STRIPS WERE REQUESTED FOR INVESTIGATION, HOWEVER, THE CUSTOMER DECLINED TO RETURN THE TEST STRIPS. THE RETENTION MATERIAL OF LOT 52422100 WERE VISUALLY TESTED WITH ERYTHROCYTES AND LEUCOCYTES-DILUTION-SERIES AND 0-NATIVE-URINE. THE RETENTION MATERIAL FULFILL THE REQUIREMENTS. NO ABNORMALITIES 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 INITIAL REPORTER COMPLAINED OF QUESTIONABLE RESULTS FOR 1 PATIENT TESTED WITH COMBUR-9-TEST URINE TEST STRIPS. FOR THE LEUKOCYTES AND ERYTHROCYTES PARAMETERS, THE RESULTS WERE "NOT INDICATED" BUT THE RESULTS FROM THE HOSPITAL WERE "PATHOLOGICAL." THE SPECIFIC RESULTS WERE NOT PROVIDED. THE CUSTOMER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
THE TEST STRIPS WERE RETURNED. THE MATERIAL SHOWED NO SIGNS OF DAMAGE OR ABNORMALITIES. THE CUSTOMER'S MATERIAL OF LOT 52422101 WAS CHECKED BY VISUAL FUNCTION WITH AN ERYTHROCYTES-DILUTION-SERIES, AN LEUCOCYTES-DILUTION-SERIES AND 0-NATIVE-URINE. THE CUSTOMER'S MATERIAL FULFILL THE REQUIREMENTS. NO ABNORMALITIES WERE OBSERVED.