MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 HCG; HCG ASSAY

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 09/08/2022

Event Type  malfunction  

Event Description

The customer observed a discordant elevated patient sample result on immulite 2000 hcg assay.When the same sample and redrawn samples were remeasured on the same immulite instrument, the results were lower.The initial result was reported to the physician, who questioned the result.A frozen embryo transfer has been delayed 1 month (1 menstrual cycle) due to the incorrect result.There are no allegations of patient harm or delays in diagnosis in association with the discordant immulite hcg result.

Manufacturer Narrative

The customer observed a discordant elevated patient sample result on immulite 2000 hcg assay.When the same sample and redrawn samples were remeasured on the same immulite instrument, the results were lower.Two levels of quality control biorad - lot 40400, were processed on (b)(6) 2022 at 8:30am.-level 1 - 11.3 (mean 9.72 sd 2.30) -level 2 - 31.8 (mean 26.0 sd 4.45) the sst tube was allowed to clot for 20 minutes, then spun at 3400 rpm for 4 minutes.Customer will run the 3 controls and 3 patients n=5.The limitations section of the immulite 2000 hcg instructions for use states: "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.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2022-00317 on oct 06, 2022.Nov 10, 2022 and dec 06, 2022 additional information: the customer reported a falsely elevated discordant result on immulite 2000 human chorionic gonadotropin (hcg) assay with kit lot 471.On (b)(6) 2022, a patient sample initially resulted 20.1 miu/ml which was reported and questioned by the physician.The same sample as well as a new draw from this patient was retested the following day with results of 1.0 miu/ml.Hcg kit lot 471 adjustment and qc results at time of this event were acceptable.The customer is aware of urgent medical device correction imc22-04 dated (b)(6) 2022 regarding potential carryover from high samples.The sample run just prior to the discordant was tested for hcg and resulted well below 5000 miu/ml so carryover is not suspected to have caused the falsely elevated result.A total service call was performed for this issue but no instrument issues were identified.Post service precision was performed and no further hcg concerns have been raised by the customer.Siemens has reviewed internal kit release data for lot 471 which expired on nov 30, 2022 and all data was well within acceptable limits.Siemens cannot definitively determine the cause of this discrepant result.Contributing factors such as pre-analytics and/or sample handling cannot be ruled out.No potential product performance issue was identified.The system is operational.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: IMMULITE 2000 HCG
• Type of Device: HCG ASSAY
• 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: 15549961
• MDR Text Key: 306432774
• Report Number: 1219913-2022-00317
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00630414961132
• UDI-Public: 00630414961132
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990222
• 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: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 10381206
• Device Lot Number: 471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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