MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY TOTAL PROTEIN II

Model Number	ADVIA CHEMISTRY TOTAL PROTEIN II
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens customer care center (ccc) specialist stated that the customer was using expired calibrator materials for the advia chemistry total protein ii assay.
Event or Problem Description
Low total protein results were obtained with the advia chemistry total protein ii reagent.The customer was using expired calibrator materials for testing.No data has been provided by the customer.The customer stated that no results were questioned.There are no known reports of any impact to patients due to this issue.

• Brand Name: ADVIA CHEMISTRY TOTAL PROTEIN II
• Common Device Name: ADVIA CHEMISTRY TOTAL PROTEIN II
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 8240498
• Report Number: 2432235-2019-00034
• Device Sequence Number: 2120468
• Product Code: CEK
• UDI-Device Identifier: 00630414465227
• UDI-Public: 00630414465227
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2019

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 Expiration Date: 05/28/2019
• Device Model Number: ADVIA CHEMISTRY TOTAL PROTEIN II
• Device Catalogue Number: 10311878
• Device Lot Number: 432852
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1