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

Model Number IMMULITE 2000 HCG

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2018

Event Type  malfunction  

Manufacturer Narrative

A siemens headquarter support center (hsc) specialist stated that the customer did not follow the intended use for this device as stated in the product's instructions for use (ifu).The intended use for immulite 2000 hcg assay as per the ifu is as follows: for in vitro diagnostic use with the immulite 2000 systems analyzers - for the quantitative measurement of human chorionic gonadotropin (hcg) in serum, and for strictly qualitative determinations in urine, as an aid in the detection of pregnancy.The cause of the discordant results with the immulite 2000 hcg assay is unknown.Siemens is investigating the issue.

Event Description

Discordant results between two replicates were obtained for a patient sample with the immulite 2000 hcg (human chorionic gonadotropin) assay.It is not known if any of the results were reported to physician(s).There are no known reports of any impact to patient treatment or intervention due to the discordant hcg results.

Manufacturer Narrative

The initial mdr 2432235-2018-00157 was filed on 18-apr-2018.Additional information (18-may-2018): a siemens headquarter support center (hsc) specialist stated that the instrument files, service history, lot numbers or calibration/control data information were not provided for investigation.The immulite 2000 hcg assay is intended to be used to measure human chorionic gonadotropin (hcg) as an aid in the detection of pregnancy as stated in the instructions for use.A siemens product issue has not been identified.The cause of the discordant results for a male patient diagnosed with a malignant germ cell tumor with the immulite 2000 hcg assay is unknown.The immulite 2000 hcg assay is performing according to specifications.No further evaluation of the device is required.

• Brand Name: IMMULITE 2000 HCG
• Type of Device: IMMULITE 2000 HCG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• MDR Report Key: 7439547
• MDR Text Key: 106015716
• Report Number: 2432235-2018-00157
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00630414961132
• UDI-Public: 00630414961132
• Combination Product (y/n): N
• PMA/PMN Number: K990222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000 HCG
• Device Catalogue Number: L2KCG2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1