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 Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2020
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.The cse replaced a high-speed spinner at an earlier date.Upon revisiting, cse noticed that the attached wheel was not spinning on the motor.The cse tightened the screws holding the assembly together, reran quick checks.System was fully functional upon departure.Siemens concluded that the potential cause of the discordant, falsely high intact pth patient result was the spinner component malfunction.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely high intact pth patient result was obtained on an immulite 1000 instrument.The initial result was not reported to the physician(s).The same sample was repeated on the same instrument and again on an alternate immulite 1000 instrument.The repeated result from the alternate instrument was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely high intact pth patient result.

• Brand Name: IMMULITE 1000
• Common Device Name: IMMULITE 1000
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley road; flanders, nj
• MDR Report Key: 9742066
• Report Number: 2247117-2020-00011
• Device Sequence Number: 13903913
• Product Code: JJE
• UDI-Device Identifier: 00630414947440
• UDI-Public: 00630414947440
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K022603
• 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): 02/21/2020

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: 01/29/2020
• Initial Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1