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

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	07/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside of the u.S.Reported observation of depressed immulite 2000 hcg results which were discordant relative to replicate testing.The ifu states in the interpretation of results section: "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 reports observation of depressed immulite 2000 hcg results which were discordant relative to replicate testing.The customer obtained initial immulite 2000 hcg results for two patients which were above the assay's 95% reference range for nonpregnant females.Repeat testing using the same method and instrument produced lower results, which was considered discordant relative to clinical expectation.There are no allegations of patient intervention or adverse health consequences due to the discordant hcg result.
Additional Manufacturer Narrative
Mdr 1219913-2022-00321 was initially filed on 2022-09-30.Additional information, 2022-12-01: siemens has concluded the investigation.A customer from outside of the u.S.Reported observation of depressed immulite 2000 hcg results which were discordant relative to repeat testing.The customer had observed disagreement between hcg test replicates for certain patients.Local service personnel replaced the sample arm motor, sample level-sense pcb, and cable on the immulite 2000 xpi analyzer, but the reported issue continued.Siemens reviewed internal test data for the involved hcg kit lot and all data were found to be well within acceptable limits.A review of customer complaints revealed only one other complaint for the reagent lot, which was resolved locally by service intervention.Based on the review of the customer and internal data, siemens provided some additional hardware recommendations for this customer's system.These recommendations represent normal troubleshooting and/or maintenance actions for an issue of this nature.Following instrument service, precision testing was performed using tsh and hcg assays as indicators.Results for both assays demonstrated acceptable precision.No additional issues were reported.A product performance issue has not been identified.Note: in section h6, the codes for investigation findings and investigation conclusion have been updated.

• Brand Name: IMMULITE 2000 HCG
• Common Device Name: HUMAN CHORIONIC GONADOTROPIN IMMUNOASSAY
• 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: 15525508
• Report Number: 1219913-2022-00321
• Device Sequence Number: 2506681
• Product Code: DHA
• UDI-Device Identifier: 00630414961132
• UDI-Public: 00630414961132
• Combination Product (Y/N): N
• Initial Reporter Country: UP
• PMA/510(K) Number: K990222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 12/07/2022

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 Expiration Date: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 10381206
• Device Lot Number: 470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 10/01/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• 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 Sex: Female