MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI OM-MA; IMMULITE 2000 OM-MA

Model Number N/A

Device Problem Low Test Results (2458)

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

Event Date 07/29/2022

Event Type  malfunction  

Manufacturer Narrative

A united states customer contacted the siemens customer care center (ccc) to report depressed immulite 2000 xpi om-ma (ca125) diluted results when compared to repeat diluted results on the same instrument.The limitations section of the instructions for use states the following: "for diagnostic purposes, the results obtained from this assay should always be used in combination with the clinical examination, patient medical history, and other findings." siemens continues to investigate.

Event Description

The customer observed depressed immulite 2000 xpi om-ma (ca125) diluted results for a patient sample compared to repeat diluted results using the same instrument.The initial result read above assay measuring range (500 u/ml) and onboard dilutions were performed three times with the same sample.Discordant low results were observed with the first set of diluted sample results.The initial diluted results were not reported to the physician(s).There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant immulite 2000 xpi om-ma (ca125) results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2022-00240 on 09-aug-2022.Additional information 11-aug-2022: siemens healthcare diagnostics has concluded its investigation of a report from an outside the united states customer regarding immulite 2000 xpi om-ma (ca125) depressed diluted results for a patient sample compared to repeat diluted results using the same instrument.Siemens' investigation determined via review of the system log files that the cause of the low dilution recovery results were that a barcode was manually overwritten by the user with the wrong sample id.The immulite 2000 xpi om-ma (ca125) lot 310 is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.In section h6, the investigation findings and investigation conclusions codes were updated.

• Brand Name: IMMULITE 2000 XPI OM-MA
• Type of Device: IMMULITE 2000 OM-MA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; gwynedd, llanberis ll55 4el ; UK
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; gwynedd, llanberis ll55 4el ; UK
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 15195580
• MDR Text Key: 304961438
• Report Number: 1219913-2022-00240
• Device Sequence Number: 1
• Product Code: LTK
• UDI-Device Identifier: 00630414961798
• UDI-Public: 00630414961798
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983391
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 10380972
• Device Lot Number: 310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1