AUTOMATE 2550
Received Mar 18, 2023 · Event occurred Feb 18, 2023
Report 3006655511-2023-00006 · MDR key 16569801
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Beckman Coulter Biomedical GmbhModel number
AUTOMATE 2550Catalog number
ODL25255
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE SORTING DRIVE OF THEIR AUTOMATE 2550 IS ALIQUOTING THE WRONG TUBE AND STORING THE CORRECT TUBE WHICH RESULTED IN THE RELEASE OF FALSE TROPONIN PATIENT RESULTS. THE CUSTOMER REPORTED THAT THERE WAS A CHANGE IN PATIENT TREATMENT; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
THE CUSTOMER DID NOT PROVIDE INFORMATION RELATING TO THE CHANGE IN PATIENT TREATMENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE AUTOMATE 2550. THE LOG FILES FROM THE INSTRUMENT WERE REVIEWED. THE FSE AND APPLICATION SUPPORT MANAGER DETERMINED THAT THE FILES INDICATE THAT THE CUSTOMER MAY HAVE HAD TWO TUBES FROM TWO DIFFERENT PATIENTS. THE LOG FILES DID NOT INDICATE AN ISSUE WITH THE INSTRUMENT. THERE IS NO EVIDENCE OF A INSTRUMENT MALFUNCTION. THE CUSTOMER WAS SATISFIED WITH THE SUPPORT AND NO FURTHER ISSUES WERE REPORTED. INITIAL REPORTER TELEPHONE NUMBER IS (B)(6). THE BECKMAN COULTER INTERNAL IDENTIFIER IS CASE (B)(4).