MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI CMV IGG (CVG); IMMULITE 2000 CMV IGG (CVG)

Model Number N/A

Device Problem False Negative Result (1225)

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

Event Date 06/14/2022

Event Type  malfunction  

Event Description

The customer reports observation of a false-positive immulite 2000 cmv igg (cvg) result for one patient which was discordant relative to clinical indications and repeat testing.An initial negative cvg result was obtained for this patient on (b)(6) 2022, and reported to the physician.The physician questioned the result, and repeat testing was performed on the same instrument, producing a positive result which was accepted as correct.The negative cvg result was not consistent with positive indications from other tests.There are no known reports of patient intervention or adverse health consequences due to the discordant, negative cmv igg patient results.

Manufacturer Narrative

A customer from outside the united states has reported observation of a false-negative immulite 2000 cmv igg (cvg) result for one patient which was discordant relative to clinical indications and repeat testing.No other problem indications were noted.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.".

Manufacturer Narrative

Mdr 1219913-2022-00184 was initially filed on 2022-06-24.Correction: in the original report, section b5, it was stated that a "false-positive" result had been reported.This should have indicated "false-negative".The allegation was that a false negative result had been observed.Additional information, 2022-09-22: siemens has concluded investigation.A customer from outside the united states reported observation of a false-negative immulite 2000 cmv igg (cvg) result for one patient which was discordant relative to clinical indications and repeat testing.Siemens has reviewed the available information, and a cause for the initial low result could not be determined.Service history for the affected system show some earlier issues with foam in the dilution well, which may have been a contributing factor.The system files are no longer available for review/investigation.Initial file review, however, did not show any issues with pipetting of the sample or reagents.The local service team performed several mechanical interventions for issues which were unrelated to the discordant result; siemens is unable to determine whether these interventions may have had an influence.The sample was initially tested using kit lot 365, and repeat-tested using lot 366.Comparison of in-house data for these two lots showed that there were no tested samples that changed clinical interpretation between lots.Siemens requested the affected sample, but it was not provided.Siemens is unable to determine if the initial result is reproducible if re-tested with lot 365.No additional issues have been reported.A product performance issue has not been identified.The customer is operational; no further investigation is required.

• Brand Name: IMMULITE 2000 XPI CMV IGG (CVG)
• Type of Device: IMMULITE 2000 CMV IGG (CVG)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer Contact: barry ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 14806073
• MDR Text Key: 302880002
• Report Number: 1219913-2022-00184
• 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
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• 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: 09/22/2022
• 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