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 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After analyzing the instrument, the cse performed system decontamination with sodium hydroxide solution.The cse then reviewed the mechanical positions of probes, dual resolution dilutors and verified hydraulics couplings.The siemens technical application specialist performed repeatability testing on the patient sample.The customer stated that the patient had a breast cancer and any positive hcg result is considered important for the treatment of the patient.As per immulite 2000 hcg instructions for use, the intended use of hcg is "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." therefore, hcg was being run by the customer for an off-label use.The cause of the discordant, falsely elevated hcg results on one patient sample is unknown.Siemens is investigating the issue.Mdr 2432235-2018-00008 was filed for the same event.Mdr 2432235-2018-00009 was filed for the event occurred on (b)(6) 2017.

Event Description

The customer obtained discordant, falsely elevated human chorionic gonadotropin (hcg) results on one patient sample on an immulite 2000 xpi instrument, while using reagent lot 386 and 387.The results from the immulite 2000 xpi instrument were reported to the physician(s).The sample was repeated on an alternate platform, resulting lower and matching the clinical history of the patient.The corrected result from the alternate platform was reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated hcg results.

Manufacturer Narrative

The initial mdr 2432235-2018-00012 was filed on 04-jan-2018.Additional information (04-jan-2018): the sample id in question was (b)(6).Sections have been updated with this information.The customer uses human chorionic gonadotropin (hcg) for tumor marker detection.Quality control was within acceptable range.No sample is available for in-house testing.Mdrs 2432235-2018-00008_s1, 2432235-2018-00009_s1, 2432235-2018-00040, 2432235-2018-00041, and 2432235-2018-00042 were filed for the same issue.

Manufacturer Narrative

The initial mdr 2432235-2018-00012 was filed on 04-jan-2018.The first supplemental mdr 2432235-2018-00012_s1 was filed on 30-jan-2018.Additional information (07-feb-2018): a siemens headquarters support center (hsc) specialist reviewed the event data.The human chorionic gonadotropin (hcg) results were reproducible on immulite 2000 xpi instrument across multiple draws for the sample in question.Quality control and other patient samples were not affected.The hsc specialist stated the issue only affected this patient sample.A list of medication taken by the patient is not available.Hcg reagent has been formulated to minimize the risk of interference.However, potential interactions between rare sera and test components can occur.For diagnostic purposes, the results obtained from this assay should always be used in combination with the clinical examination, patient medical history, and other finding.Based on the information provided, there is no known device issue.The device is performing within manufacturing specifications.No further evaluation of device is required.Mdrs 2432235-2018-00008_s2, 2432235-2018-00009_s2, 2432235-2018-00040_s1, 2432235-2018-00041_s1, and 2432235-2018-00042_s1 were filed for the same issue.

• 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: 7165720
• MDR Text Key: 96726694
• Report Number: 2432235-2018-00012
• 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,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• 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
• Device Lot Number: 387
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1