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

Model Number IMMULITE 2000 FREE PSA

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

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

Event Date 08/10/2018

Event Type  malfunction  

Manufacturer Narrative

A siemens customer care center (ccc) specialist stated that the assay adjustments and quality control material recoveries were within range.Adjustment and quality control data from the customer has been provided for investigation.The cause of the discordant, falsely elevated results with the immulite 2000 free psa assay is unknown.Siemens is investigating the issue.Mdr 2432235-2018-00345 and mdr 2432235-2018-00346 were filed for the same issue.

Event Description

Discordant, falsely elevated results were obtained on two different samples from the same patient with the immulite 2000 free psa assay on an immulite 2000 xpi instrument.The discordant results were not reported to the physician(s).The samples were repeated on an alternate platform.The results from the alternate platform were lower and in alignment with the clinical profile of the patient.One of the results from the alternate platform was reported to the physician(s).There are no known reports of any impact to patient treatment or intervention due to the discordant, falsely elevated free psa results.There are no known reports of a delay in administering treatment or medical intervention to the patient due to the discordant, falsely elevated free psa results.

Manufacturer Narrative

The initial mdr 2432235-2018-00344 was filed on (b)(6) 2018.Additional information (22-oct-2018): a siemens headquarter support center (hsc) specialist inquired about the availability of the samples for testing by siemens and if heterophilic blocking tests could be performed on the samples, but no information was provided.The hsc specialist reviewed the adjustment and quality control data provided by the customer.The hsc specialist stated that the adjustment and quality control recoveries were within range and comparable with the release data.There is no indication of an assay performance issue with immulite 2000 free psa lots 307 and 308.There is no indication of an instrument malfunction contributing to the discordant results.The hsc specialist stated that heterophiles present in the sample can affect the quality of the sample and lead to erroneous results.This cannot be ruled out as a contributing factor of the falsely elevated results.The interference could come from endogenous antibodies, drugs, nutritional supplements and/or herbal medicine in the blood.Additional information (31-oct-2018): a siemens customer care center (ccc) specialist stated that treatment of the samples with a heterophilic blocking tube (hbt) or non-specific antibody blocking tube (nabt) was not performed.The samples were not available for testing by siemens.The patient did not have any relevant medical condition.The cause of the discordant, falsely elevated results with the immulite 2000 free psa assay is unknown.The assay is performing according to specifications.No further evaluation of the device is required.Mdr 2432235-2018-00345_s1 and mdr 2432235-2018-00346_s1 were filed for the same issue.

• Brand Name: IMMULITE 2000 FREE PSA
• Type of Device: IMMULITE 2000 FREE PSA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• MDR Report Key: 7894129
• MDR Text Key: 121443816
• Report Number: 2432235-2018-00344
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• PMA/PMN Number: P060005
• 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: 11/15/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: IMMULITE 2000 FREE PSA
• Device Catalogue Number: L2KPF2
• Device Lot Number: 307
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/20/2018
• Supplement Dates Manufacturer Received: 10/22/2018
• Supplement Dates FDA Received: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR