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 05/23/2022

Event Type  malfunction  

Event Description

The customer observed initial, negative immulite 2000 xpi cmv igg (cvg) results for four patients that were positive upon repeat testing on the same immulite 2000 xpi.The patients were expected to be positive based on historical data.One sample was also positive on two alternate methods.Previous numeric results were not provided.The negative immulite 2000 xpi cmv igg (cvg) results were reported to the physician(s) who questioned the results.There are no known reports of patient intervention or adverse health consequences due to the discordant, negative cmv igg patient results.

Manufacturer Narrative

An outside of the united states (ous) customer contacted the siemens customer care center (ccc) to report initial, negative immulite 2000 xpi cmv igg (cvg) results for four patients that were positive upon repeat testing on the same immulite 2000 xpi.The patients were expected to be positive based on historical data.One sample was also positive on two alternate methods.Previous numeric results were not provided.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 is investigating.

Manufacturer Narrative

The initial mdr 1219913-2022-00166 was filed on june 3, 2022.Additional information - june 14 2022.An outside of the united states (ous) customer contacted the siemens customer care center (ccc) to report initial, negative immulite 2000 xpi cmv igg (cvg) results for four patients that were positive upon repeat testing on the same immulite 2000 xpi.The patients were expected to be positive based on historical data.One sample was also positive on two alternate methods.Previous numeric results were not provided.An application specialist went on site and performed troubleshooting studies looking at different rack positions with multiple assays and gathered system files.Additional checks of the dilution station were made and no abnormal results were observed.An initial review of the system files was performed and there were no issues identified with level sensing of the sample, reagent or the diluent.No service or replacement of parts has been performed and the customer has not moved to a new lot of reagents.The customer is currently using sarstaedt monovette 7.5 ml and vacutainer 9 ml sample tubes.Siemens continues to investigate.

Manufacturer Narrative

The initial mdr 1219913-2022-00166 was filed on june 3, 2022 and mdr 1219913-2022-00166 supplemental 1 was filed on july 13, 2022.Additional information -august 5, 2022.An outside of the united states (ous) customer contacted the siemens customer care center (ccc) to report initial, negative immulite 2000 xpi cmv igg (cvg) results for four patients that were positive upon repeat testing on the same immulite 2000 xpi.The patients were expected to be positive based on historical data.One sample was also positive on two alternate methods.Previous numeric results were not provided.Siemens reviewed files from the instrument.The spyfiles showed no issues when pipetting the cvg reagent for the tests in question.The encoder readings for both compartments 0 and 1 were in the range of expected values.The spyfiles showed no issues when pipetting sample from the sample tubes and diluent from the diluent tube for the tests in question.Again, the encoder readers were in the range of expected values.The spyfiles did show an issue when pipetting sample from the dilution well for the cvg tests in question.The encoder readings when pipetting from the dilution well for the tests with the discordant results were in the 4000-4100+ range.Cvg tests that resulted in the normal range had encoder reading from the dilution well in the 4300-4400+ range.The same is true for the 'bad' accession numbers when they were rerun.The encoder readings in the dilution well were in the 4300-4400+ range.For the tests in question with low results, it appears that they 'short sampled' in the dilution well.The sample pipettor may have level sensed on foam or a bubble in the dilution well which would account for the higher than expected encoder reading when pipetting sample from the dilution well.Since the sample pipettor did not dive deep enough into the liquid, the amount of sample drawn was less than optimal which potentially produced a lower than expected result.Siemens continues to investigate.

Manufacturer Narrative

The initial mdr 1219913-2022-00166 was filed on june 3, 2022, mdr 1219913-2022-00166 supplemental 1 was filed on july 13, 2022 and mdr 1219913-2022-00166 supplemental 2 was filed on september 2, 2022.Additional information -october 10, 2022.An outside of the united states (ous) customer contacted the siemens customer care center (ccc) to report initial, negative immulite 2000 xpi cmv igg (cvg) results for four patients that were positive upon repeat testing on the same immulite 2000 xpi.The patients were expected to be positive based on historical data.One sample was also positive on two alternate methods.Previous numeric results were not provided.Siemens reviewed instrument support files and no cause could be determined for the initial low sample results.Siemens' review of the instrument support files did indicate that the results in question appeared to level sense higher in the dilution well than the results that were considered normal.Due to this observation there is a potential that level sensing within the dilution well contributed to the false negative results, however this determination is not conclusive.A check of the dilution well assembly was performed.Several mechanical interventions that were unrelated were performed, however siemens is unable to determine if they contributed to the initial low result.System is currently operational and no further request for assistance was received.Customer has moved cmv testing to the atellica im.No product non conformance identified with regard to hardware or reagent.In section h6, the investigation finding, and investigation conclusion codes were updated.

• 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; 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: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 14598491
• MDR Text Key: 301044209
• Report Number: 1219913-2022-00166
• 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: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• 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: 10/10/2022
• 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