MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 1000 VITAMIN B12; IMMULITE 1000 VITAMIN B12

Model Number	IMMULITE 1000
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens investigated the event and determined the operator did not follow the instructions in the immulite/immulite 1000 vitamin b12 instructions for use, which instructs the user to use extreme care to avoid all bodily contact with this reagent, due to the presence of cyanide.In addition, the safety data sheet indicates the individual protection measures for skin protection when using this product.The operator was not wearing personal protective equipment (ppe) when using the vitamin b12 borate kcn buffer solution.The cause of the event was due to the operator not following the instructions in the instructions for use or the safety data sheets.No further evaluation of the device is required.The system is performing within manufacturing specifications.
Event or Problem Description
Siemens was informed that while using the vitamin b12 borate kcn buffer solution, 20-30 ml of the buffer spilled on the operator's legs.The operator's skin was red at the site of the buffer contact area but faded after a short period of time.The customer informed siemens that the operator was wearing gloves at the time of use.The operator consulted a physician(s).It is unknown if any medical treatment was rendered.There was no report of adverse health consequences due to the spill of the buffer solution on the operator.

• Brand Name: IMMULITE 1000 VITAMIN B12
• Common Device Name: IMMULITE 1000 VITAMIN B12
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis; gwynedd, LL55 4EL; UK LL55 4EL
• MDR Report Key: 8217112
• Report Number: 2432235-2019-00003
• Device Sequence Number: 1656558
• Product Code: LIG
• UDI-Device Identifier: 00630414964874
• UDI-Public: 00630414964874
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K993251
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IMMULITE 1000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1