COULTER PREPPLUS 2
Received Sep 19, 2023 · Event occurred Aug 24, 2023
Report 1061932-2023-00103 · MDR key 17778239
Device
Generic name
Automated Pipetting, Diluting Specimen Workstation For Flow Cytometric Analysis
Manufacturer
Beckman Coulter, Inc.Model number
FINAL ASSY PREP PLUS 2Catalog number
378600
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE FIELD SERVICE ENGINEER (FSE) WAS AT THE CUSTOMER SITE AND WAS ABLE TO CONFIRM TH REPORTED ISSUE. THE CAUSE OF THE ISSUE WAS FOUND TO BE THE PROBE TUBING POPPING OFF THE PROBE BASE. THE FSE REPLACED THE PROBE TUBING WITH NEW TUBING TO RESOLVE THE REPORTED ISSUE AND THE WASTE WELL WAS REPLACED AS A PREVENTATIVE MEASURE. BEC INTERNAL IDENTIFIER - (B)(4).
Description of Event or Problem
THE CUSTOMER REPORTED THE PREPPLUS2 RANDOMLY FAILED TO ADD BLOOD TO DAUGHTER TUBE WHEN PREPARING SAMPLES. REVIEW OF THE HISTOGRAMS/RESULTS CAUSED THE USER TO QUESTION THE RESULTS RUN ON FLOW CYTOMETRY ANALYZER. THE USER CONFIRMED THAT BLOOD WAS NOT ADEQUATELY ADDED TO SOME PATIENT SAMPLE PREPARATIONS. THE CUSTOMER WAS ASKED WHAT SPECIFIC RESULTS WERE IMPACTED BUT THE CUSTOMER DID NOT PROVIDE SPECIFIC INFORMATION REGARDING THE RESULTS. PER THE CUSTOMER, SOME ERRONEOUS RESULTS WERE GENERATED BUT WERE NOT REPORTED OUT OF THE LAB. THE SAMPLES WERE RE-PREPARED AND RE-RUN. THERE WAS NO ADVERSE EVENT REPORTED FOR THIS ISSUE. THERE WAS NO IMPACT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.