MAUDE Adverse Event Report: BECKMAN COULTER BIOMEDICAL GMBH DXA 5000 FIT INPUT/OUTPUT WITH DECAPPER; RADIOASSAY, VITAMIN B12

Model Number DXA-INPUT-OUTPUT-DEC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Eye Injury (1845)

Event Date 02/02/2022

Event Type  Injury  

Event Description

The customer reported that when removing full archive rack with samples from outlet (back position) of the dxa instrument some of primary tubes was/were blocked.The frame needed additional manipulation that serum was sprayed outside and accidentally also into the eyes of technician working with instrument.The technician washed their eyes and received antibiotics.No further harm was reported.No patients were involved in this incident.

Manufacturer Narrative

Beckman coulter customer technical support (cts) provided support and documented the details of the event.The beckman coulter field service engineer evaluated the dxa, and confirmed that the technician struggled to remove the rack of tubes from for back position of the drawer.The fse confirmed that the drawers, once fully opened, are designed in such a way that the removal of a rack placed in back position is possible without constrain and in a safe manner.Possible resistance has been discussed with a dxa mechanical engineer, and it originates in the inner sliders from the drawers, which get "stacked" with time, and need to be "firmly pulled" periodically to ensure full range of motion of the opened rack.The issue will continue to be evaluated.Initial reporter telephone number is (b)(6).The beckman coulter internal identifier is (b)(4).

Event Description

The customer reported that when removing full archive rack with samples from outlet (back position) of the dxa instrument some of primary tubes was/were blocked.The frame needed additional manipulation that serum was sprayed outside and accidentally also into the eyes of technician working with instrument.On (b)(6) 2022, the technician confirmed that they washed their eyes and received treatment with antibiotics.No further harm was reported.No patients were involved in this incident.

• Brand Name: DXA 5000 FIT INPUT/OUTPUT WITH DECAPPER
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): BECKMAN COULTER BIOMEDICAL GMBH; sauerbruchstr. 50; münchen 81377 ; GM 81377
• Manufacturer (Section G): BECKMAN COULTER BIOMEDICAL GMBH; sauerbruchstr. 50; münchen 81377 ; GM 81377
• Manufacturer Contact: alex schwiersch ; sauerbruchstr. 50; münchen 81377 ; GM 81377
• MDR Report Key: 13654635
• MDR Text Key: 290383328
• Report Number: 3006655511-2022-00002
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 15099590739942
• UDI-Public: (01)15099590739942(11)210209
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K190298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DXA-INPUT-OUTPUT-DEC
• Device Catalogue Number: C44570
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2022
• Initial Date FDA Received: 03/02/2022
• Supplement Dates Manufacturer Received: 02/07/2022
• Supplement Dates FDA Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other