MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI HUMAN CHORIONIC GONADOTROPIN (HCG); HUMAN CHORIONIC GONADOTROPIN IMMUNOASSAY

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 09/05/2022

Event Type  malfunction  

Manufacturer Narrative

An outside the united states (ous) customer contacted the siemens customer care center (ccc) reporting discordant elevated immulite 2000 xpi hcg results on 2 patient serum samples.The limitations section of the ifu 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." mdr 1219913-2022-00332 was filed for the same issue.Siemens is investigating.

Event Description

The customer contacted siemens to report discordant elevated immulite 2000 xpi hcg results on 2 patient serum samples.On one patient, elevated results were obtained compared to retest results on atellica im thcg on the same day and on immulite 2000 xpi that were lower on a different day.On the other patient, results were elevated compared to retest results on atellica im thcg.The complaint indicates that the initial discordant 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 elevated hcg results.

Manufacturer Narrative

Siemens filed mdr 1219913-2022-00303 initial report on 2022-09-30.Additional information - 2022-11-10.Siemens concluded the investigation for an outside the united states (ous) customer observation of discordant elevated immulite 2000 xpi human chorionic gonadotropin (hcg) results on 2 patient serum samples.The customer repeats all hcg samples that result between 2.5 and 750 miu/l on the immulite 2000 and atellica im since receiving urgent field safety notice (ufsn) imc 22-04.A.Ous - immulite 2000/immulite 2000 xpi human chorionic gonadotropin (hcg) potential carryover from high samples.Sid # (b)(6) was tested on 2022-09-05 with results of 32 miu/ml and 11.6 miu/ml, and when repeated on atellica im was 0.1 miu/ml.The sample was repeated again on immulite 2000 xpi on 2022-09-08 and the results were 4.49 miu/ml and 3.71 miu/ml, not replicating the initially elevated results.Siemens cannot rule out preanalytical factors or sample handling as a possible cause for the discordant results for sid# (b)(6).Sid # (b)(6) was tested on 2022-09-05 with results of 4.83 miu/ml and 4.61miu/ml and when repeated on atellica im resulted 0.2 miu/ml.For sid# (b)(6), the immulite 2000 xpi replicates show good agreement.The concentration of hcg in a given sample can vary between immulite 2000 xpi and atellica im due to differences in assay methods and reagent specificity.Based on each assays instructions for use (ifu) intended use and the expected values, the results between systems show clinical agreement.Other patient samples tested using the same immulite 2000 xpi hcg lot resulted without concern.Lot 471 had a valid adjustment and bio-rad immunoassay plus quality control (qc) lot 85280 recovered within acceptable limits at the time of event.Based on the available information, immulite 2000 xpi is performing as intended and no product performance issue has been identified.The customer is operational and no further action is required.In section h6, investigation finding and investigation conclusion codes were updated based on the investigation results.Mdr 1219913-2022-00332 supplemental 1 was filed for the same issue.

• Brand Name: IMMULITE 2000 XPI HUMAN CHORIONIC GONADOTROPIN (HCG)
• Type of Device: HUMAN CHORIONIC GONADOTROPIN IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; gwynedd, llanberis LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; gwynedd, llanberis LL55 4EL; UK LL55 4EL
• Manufacturer Contact: stacy loukos ; 333 coney street; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 15524899
• MDR Text Key: 306438960
• Report Number: 1219913-2022-00303
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00630414961132
• UDI-Public: 00630414961132
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 10/01/2022
• Supplement Dates Manufacturer Received: 11/10/2022
• Supplement Dates FDA Received: 11/29/2022
• 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