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 12/12/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.Quality controls were within acceptable range.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 uses hcg for tumor marker detection.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.No sample is available for in-house testing.The cause of the discordant, falsely elevated hcg results on one patient sample is unknown.Siemens is investigating the issue.Mdrs 2432235-2018-00008_s1, 2432235-2018-00009_s1, 2432235-2018-00012_s1, 2432235-2018-00040, and 2432235-2018-00041 were filed for the same issue.

Event Description

The customer obtained discordant, falsely elevated human chorionic gonadotropin (hcg) results on one patient sample upon initial and repeat testing on an immulite 2000 xpi instrument, using an unknown reagent lot.It is unknown if the initial result was reported to the physician(s).The sample was repeated on an alternate platform, resulting lower and matching the clinical history of the patient.The 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 2432235-2018-00042 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.Result and conclusion codes have been updated.Corrected information (27-feb-2018): the initial mdr indicate that this report was filed for discordant result obtained on sample id (b)(6).The correct sample id for this report is (b)(6).Mdrs 2432235-2018-00008_s2, 2432235-2018-00009_s2, 2432235-2018-00012_s2, 2432235-2018-00040_s1, and 2432235-2018-00041_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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; uk registration #: 3002806944; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer Contact: shweta gulati ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242870
• MDR Report Key: 7229248
• MDR Text Key: 98647587
• Report Number: 2432235-2018-00042
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K990222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• 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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1