MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 1000

Model Number	IMMULITE 1000
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) and a siemens customer service engineer (cse) was dispatched to the customer's site and inspected the instrument.Cse performed a total service on the analyzer including the dispensers and wash speed.The customer ran multiple tests with the sample to verify precision and was acceptable.Siemens concluded that the potential cause is the particular reagent wedge used in this scenario.System was operational upon departure.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Four discordant, falsely elevated progesterone patient results were obtained on an immulite 1000 instrument.The initial results were not reported to the physician(s).The same samples were repeated on an alternate advia centaur instrument.The repeat results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated progesterone patient results.

• Brand Name: IMMULITE 1000
• Common Device Name: IMMULITE 1000
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley road; flanders NJ 07836
• MDR Report Key: 11040747
• Report Number: 2247117-2020-00065
• Device Sequence Number: 11024739
• Product Code: JJE
• UDI-Device Identifier: 00630414947440
• UDI-Public: 00630414947440
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K970227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 12/18/2020

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 Catalogue Number: 10380058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1