DXA 5000
Received Feb 1, 2021 · Event occurred Jan 7, 2021
Report 3006655511-2021-00001 · MDR key 11263379
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Beckman CoulterModel number
ASSY, MAIN, PRIMARY, DRIVE, DUAL - TRANCatalog number
B50516
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
A CUSTOMER TECHNICAL SUPPORT (CTS) WAS DEDICATED TO TROUBLESHOOT THE ISSUE WITH THE CUSTOMER. THE CTS CONFIRMED THAT THE ISSUE WAS DUE TO NON CENTRIFUGED SAMPLE. THE CUSTOMER SPUN THE SAMPLE IN AN EXTERNAL CENTRIFUGE AND REPROCESSED THE SAMPLE TO RESOLVE. (B)(4). NO PATIENT DEMOGRAPHIC INFORMATION (AGE, GENDER, WEIGHT, RACE OR ETHNICITY) WAS PROVIDED. (B)(6).
Description of Event or Problem
THE CUSTOMER REPORTED A NON CENTRIFUGED SAMPLE BY THE DXA 5000 SYSTEM CAUSED AN ERRONEOUS PATIENT RESULT WITH MULTIPLE CHEMISTRIES TO BE GENERATED ON THE AU5800 CLINICAL CHEMISTRY ANALYZER. THERE WAS NO CHANGE IN PATIENT TREATMENT IN ASSOCIATION WITH THIS EVENT.
Remedial action
- Recall