MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE UNCONJUGATED ESTRIOL (UE3); RADIOIMMUNOASSAY, ESTRIOL

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center (ccc) to report a falsley depressed immulite 2000 xpi unconjugated estriol (ue3) result.The complaint information indicated that the result was obtained on an instrument with an out of range adjustment.The assay procedure section of the instructions for use (ifu) states: "note that for optimal performance, it is important to perform all routine maintenance procedures as defined in the immulite 2000 systems operator's manual.See the immulite 2000 systems operator's manual for preparation, setup, dilutions, adjustment, assay and quality control procedures." the limitations section of the instructions for use (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." siemens is investigating.
Event or Problem Description
The customer ran a prenatal screening sample on immulite 2000 xpi unconjugated estriol (ue3), which was out of adjustment.This led to a falsely depressed ue3 result, indicating high-risk for trisomy 18.Upon retest, the ue3 result was higher (low risk for trisomy 18).It is currently unclear whether the initial falsley depressed result was reportied to the physician.There are no reports that treatment was altered or prescribed or adverse health consequences due to the ue3 result.
Additional Manufacturer Narrative
Siemens healthcare diagnostics filed mdr initial report on 2022-09-07.Additional information - 2022-09-07.The customer confirmed that the initial result was not reported; only the correct result was reported to the physician.The customer confirmed the instrument was not serviced by a third party; section d8 of this report has been updated.Additional information -2022-09-13.Siemens reviewed the additional data provided by the customer (readjustment, control and patient retest).The data suggests that the reason for the initial high risk trisomy 18 (low unconjugated estriol) result may not be related to the overdue adjustment, but potential imprecision in the sample itself.As it is the same kit lot in use, it is unlikely an issue with the kit lot itself.Additional information - 2022-09-27.Siemens concluded the investigation for an oustside of the united states (ous) customer observation of a high trisomy 18 risk affiliated with a low unconjugated estriol (ue3) result on the immulite 2000 xpi.Initially, the customer ran the patient sample on ue3 reagent lot 491, which was out of adjustment.A discordant result of was 0.638 nmol/l was obtained.The sample was repeated and did result higher (0.992 nmol/l).The sample was then rerun after a new adjustment with the same kit lot 491 and the value was higher (1.19 nmol/l).No other samples were affected and there was no report of quality control out of range, therefore root cause does not appear to be related to the adjustment problem.Siemens does not recommend running any patient samples on kits that have not been adjusted.It is possible that pre-analytical handling attributed to imprecision in this one sample.Siemens internal data was reviewed for ue3 lot 491 and all release specifications were met.The customer has been running with no further problems.Based on the investigation, no product problem was identified.The customer is operational.In section h6, investigation finding and investigation conclusion codes were updated based on the investigation results.

• Brand Name: IMMULITE UNCONJUGATED ESTRIOL (UE3)
• Common Device Name: RADIOIMMUNOASSAY, ESTRIOL
• 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: 15372957
• Report Number: 1219913-2022-00277
• Device Sequence Number: 6744208
• Product Code: CGI
• UDI-Device Identifier: 00630414997162
• UDI-Public: 00630414997162
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2022

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 10381192
• Device Lot Number: 491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Race: Asian