PREPPLUS 2 WORKSTATION
Received Mar 10, 2021 · Event occurred Feb 18, 2021
Report 1061932-2021-00031 · MDR key 11453238
Device
Generic name
Automated Pipetting, Diluting Specimen Processing For Flow Cytometric Analysis
Manufacturer
Beckman CoulterModel number
FINAL ASSY, PREP PLUS 2Catalog number
378600
Lot number
80426939
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- 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 CONFIRMED WHAT THE CUSTOMER HAD REPORTED. THERE WAS NO MALFUNCTION OF THE NAVIOS FLOW CYTOMETRY INSTRUMENT, THE MALFUNCTION OCCURRED ON THE PREP PLUS 2 SAMPLE HANDLING DEVICE THAT WAS PREPARING THE SAMPLE FOR TESTING. THE FSE OBSERVED THAT THE PREP PLUS 2 HAD A BENT NEEDLE THE NEEDLE WOULD HIT AND TWIST SLIGHTLY AT THE BOTTOM OF THE ANTIBODIES, AND WOULD RUB SIGNIFICANTLY IN THE WASH STATION. SAMPLES WERE NOT BEING PREPARED CORRECTLY FOR TESTING. TO RESOLVE THE ISSUE THE FSE REPLACED THE NEEDLE. BEC INTERNAL IDENTIFIER CASE (B)(4).
Description of Event or Problem
THE CUSTOMER REPORTED COMPENSATION CONCERNS ON SAMPLES RUN ON THEIR NAVIOS FLOW CYTOMETRY INSTRUMENT PART NUMBER B47905, SERIAL NUMBER (B)(4). IT IS UNKNOWN HOW MANY PATIENTS WERE IMPACTED. THE INFORMATION AND DATA WAS REQUESTED FROM THE CUSTOMER BUT THEY WERE NOT ABLE TO PROVIDE SPECIFIC INFORMATION OR DATA. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.