DXA
Received Oct 25, 2021 · Event occurred Oct 7, 2021
Report 3006655511-2021-00003 · MDR key 12691229
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Beckman Coulter Biomedical GmbhModel number
DXA 5000Catalog number
B87344
Lot number
65269326
Product problems
- Improper or Incorrect Procedure or Method
- Improper or Incorrect Procedure or Method
Patient
Not reported
- Muscle/Tendon Damage
- Muscle/Tendon Damage
Narrative
Additional Manufacturer Narrative
THE FSE RECEIVED PRESCRIPTION PAIN MEDICATION AND WAS ON SICK LEAVE UNTIL (B)(6) 2021. THE FSE HAS SINCE FULLY RECOVERED FROM THE INJURY AND IS BACK ON DUTY WITHOUT REPORTING ANY FURTHER COMPLICATIONS DUE TO THE INCIDENT. THE CUSTOMER IS OPERATIONAL AND NO FURTHER CONTACT IS REQUIRED. ASSESSMENT OF THE AVAILABLE INFORMATION REVEALED, THAT DURING THE REATTACHMENT OF THE SIDE PANEL OF THE OUTPUT MODULE, THE FSE DID NOT FOLLOW INSTRUCTIONS OF THE CURRENT DXA SERVICE MANUAL SECTION "5.3.7.3 MOUNTING THE SIDE COVERS" WHICH INSTRUCTS THE INSTALLATION OF THE SIDE PANELS TO BE PERFORMED BY TWO (2) PEOPLE. (B)(6). THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).
Description of Event or Problem
DURING REPAIR OF A PUSH CAP FEEDER ERROR THE BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) SUSTAINED A SHOULDER INJURY WHILST REATTACHING THE SIDE PANEL OF THE DXA OUTPUT MODULE. THE FSE RECEIVED PRESCRIPTION PAIN MEDICATION AND WAS ON SICK LEAVE UNTIL (B)(6) 2021. NO HOSPITALIZATION WAS REQUIRED. THE FSE SINCE HAS RECOVERED FROM THE INJURY. NO ERRONEOUS PATIENT RESULTS WERE GENERATED DUE TO THIS INCIDENT.