COBAS U 701 MICROSCOPY ANALYZER
Received Jan 7, 2026 · Event occurred Dec 16, 2025
Report 1823260-2026-00081 · MDR key 23987694
Device
Product problems
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE BACTERIAL COUNT RESULTS FROM MULTIPLE URINE PATIENT SAMPLES TESTED ON THE COBAS U 701 MICROSCOPY ANALYZER. THE PATIENT'S BACTERIAL COUNT RESULTS FROM THE ANALYZER WERE NEGATIVE AND WERE DEEMED FALSE NEGATIVES. THE IMAGES OF THE PATIENT SAMPLES INDICATE THE PRESENCE OF BACTERIA.
Additional Manufacturer Narrative
THE FIELD APPLICATIONS SPECIALIST (FAS) INVESTIGATED THE EVENT, VERIFIED THAT CALIBRATION, MICROSCOPE MAINTENANCE, QCS, AND BACTERIAL COUNT ASSAY WERE ACCEPTABLE, AND CONFIRMED THAT THE ANALYZER WAS PERFORMING ACCORDING TO SPECIFICATIONS. THE FAS ALSO CONFIRMED THAT THE REPORTED URINE PATIENT SAMPLES HAD TOO MANY CELLS OR WERE CROWDED. THE INVESTIGATION REVIEWED THE PROVIDED IMAGES OF OTHER PATIENT SAMPLES AND DETERMINED THAT THEY WERE CONSISTENT WITH HIGHLY CROWDED URINE SAMPLES, TRIGGERING THE "UC" DATA FLAG. PRODUCT LABELING STATES: "RESULT HANDLING. DATA ALARMS. UC - UNRELIABLE IMAGE FOUND. THERE ARE TOO MANY CELLS IN THE IMAGE (CROWDED), AUTOMATIC EVALUATION IS NOT POSSIBLE. REVIEW IS RECOMMENDED." IN ADDITION, BACTERIA ARE RELATIVELY SMALL ORGANISMS AND MAY BE MASKED BY LARGER PARTICLES WHEN SET IN HIGHLY CROWDED SAMPLES WITH EXCESSIVE PARTICLE LOAD. THE INVESTIGATION DETERMINED THAT CROWDING IN THE URINE SAMPLES (DUE TO AN INCREASED NUMBER OF CELLS) CAUSED THE EVENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.