MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI CMV IGG; CYTOMEGALOVIRUS IMMUNOASSAY

Model Number N/A

Device Problem False Negative Result (1225)

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

Event Date 05/16/2022

Event Type  malfunction  

Event Description

The customer obtained a nonreactive (negative) immulite 2000 xpi cmv igg (cvg) result for a patient sample on (b)(6) 2022 that was considered discordant with the previous result from on (b)(6) 2022.The sample was repeated on the immulite 2000 xpi cmv igg (cvg) assay on (b)(6) 2022 and the result was reactive (positive).The discordant nonreactive (negative) result was not reported.There are no known reports of patient intervention or adverse health consequences due to the nonreactive (negative) immulite 2000 xpi cmv igg (cvg) result.

Manufacturer Narrative

An outside of the united states (ous) customer contacted the siemens customer care center to report a nonreactive (negative) immulite 2000 xpi cmv igg result for a patient sample that was considered discordant when compared to the previous reactive (positive) result.The ifu states in the limitations section: "the results of the test must be taken within the context of the patient's clinical history, symptomology and other laboratory findings." siemens healthcare diagnostics is investigating.

Manufacturer Narrative

Siemens filed the initial mdr on may 25, 2022.June 02, 2022 additional information: an outside of the united states (ous) customer contacted the siemens customer care center to report a nonreactive (negative) immulite 2000 xpi cmv igg result for a patient sample that was considered discordant when compared to the previous reactive (positive) result.The local service team completed system inspection and performed the following: the reagent probe was realigned on may 18, 2022 due to errors.There were no more errors since alignment.Completed testing of reagent and sample probe setting.Readjusted reagent blind hole and allergy wedge position minor readjustment of drd positions, reagent valve positions, tube lifter positions, pmt shutter positions and tube shaker bars.Checked water and substrate prime, sample carousel ring and grounding brush cleaned to achieve better grounding, lubricated sample and reagent probe slides.Siemens continues to investigate.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2022-00150 on may 25, 2022.Siemens filed the mdr 1219913-2022-00150 supplemental report 1 on june 14, 2022.July 13, 2022 additional information: an outside of the united states (ous) customer contacted the siemens customer care center to report a nonreactive (negative) immulite 2000 xpi cmv igg result for a patient sample that was considered discordant when compared to the previous reactive (positive) result.The dual pipettor assembly was replaced on may 02, 2022 by the customer service engineer (cse).Siemens reviewed the instrument files and there does not appear to be an issue with level sensing in the sample, reagent or the diluent.The customer is using the sample tube type sarstaedt monovette 7.5 ml and vacutainer 9 ml.The customer started to use cmv igg (cvg) lot 366 since june 3, 2022.Siemens continues to investigate.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2022-00150 on may 25, 2022.Siemens filed the mdr 1219913-2022-00150 supplemental report 1 on june 14, 2022.Siemens filed the mdr 1219913-2022-00150 supplemental report 2 on august 04, 2022.August 18, 2022 additional information: an outside of the united states (ous) customer contacted the siemens customer care center to report a nonreactive (negative) immulite 2000 xpi cmv igg result for a patient sample that was considered discordant when compared to the previous reactive (positive) result.Siemens has investigated.Siemens has reviewed the instrument files and a cause could not be determined.The local service team performed several mechanical interventions that were unrelated to the discordant result and siemens is unable to determine the cause of the initial nonreactive (negative) result.Siemens requested samples for further testing and investigation, however no samples were provided.No product nonconformance identified.No further evaluation of the device is required.

• Brand Name: IMMULITE 2000 XPI CMV IGG
• Type of Device: CYTOMEGALOVIRUS IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; llanberis, gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 7372808688
• MDR Report Key: 14495243
• MDR Text Key: 292604045
• Report Number: 1219913-2022-00150
• Device Sequence Number: 1
• Product Code: LFZ
• UDI-Device Identifier: 00630414961231
• UDI-Public: 00630414961231
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K993952
• 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,Followup,Followup,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 10381309
• Device Lot Number: 365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• 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