COMBUR 7 TEST
Received Mar 6, 2024 · Event occurred Feb 12, 2024
Report 1823260-2024-00679 · MDR key 18850827
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsCatalog number
11008552191
Lot number
67817803
Product problems
- False Negative Result
- Incorrect Measurement
- Incorrect, Inadequate or Imprecise Result or Readings
- False Negative Result
- Incorrect Measurement
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER ALLEGED FALSE NEGATIVE LEUKOCYTE RESULTS WHILE USING THE COMBUR 7 TEST STRIPS. THE CUSTOMER TESTED THE PATIENT SAMPLE MULTIPLE TIMES AND ALWAYS RECEIVED A NEGATIVE RESULT. THE PATIENT WAS TESTED USING ANOTHER MANUFACTURER TEST STRIP AND THE RESULT WAS POSITIVE. THIS WAS THE EXPECTED RESULT BASED ON THE PATIENT'S SYMPTOMS AND KNOWN CONDITION.
Additional Manufacturer Narrative
THE RETENTION MATERIAL OF LOT 67817800 WAS TESTED BY VISUAL READING WITH NATIVE-URINE AND A LEUKOCYTES-DILUTION-SERIES AND THE RESULTS WERE ACCEPTABLE. THE RETENTION MATERIAL SHOWED NO ABNORMAL RESULTS AND FULFILLED THE REQUIREMENTS. THE TEST STRIPS WERE REQUESTED FROM THE CUSTOMER FOR FURTHER INVESTIGATION. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.