MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. IMMULITE 2000 XPI SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number IMMULITE 2000 XPI SYSTEM

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2024

Event Type  malfunction  

Event Description

Falsely depressed insulin-like growth factor binding protein 3 (igfb-3) results were obtained on multiple patient samples on an immulite 2000 xpi instrument.The erroneous results were not reported to the physician(s).The samples were repeated on an alternate immulite 2000 xpi instrument.The repeat results were higher than the erroneous results.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 depressed insulin-like growth factor binding protein 3 (igfb-3) results.

Manufacturer Narrative

An outside the us customer contacted a siemens customer care center to report falsely depressed insulin-like growth factor binding protein 3 (igfb-3) results on multiple patient samples on an immulite 2000 xpi instrument.Siemens is investigating.

• Brand Name: IMMULITE 2000 XPI SYSTEM
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer Contact: jennifer cacace ; 333 coney street; east walpole, MA 02032 ; 8024302902
• MDR Report Key: 18958072
• MDR Text Key: 338557038
• Report Number: 2247117-2024-00002
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00630414945422
• UDI-Public: 00630414945422
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K970227
• 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
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000 XPI SYSTEM
• Device Catalogue Number: 10373214
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Date Device Manufactured: 07/27/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1