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

Model Number IMMULITE 2000 FREE PSA

Device Problem No Apparent Adverse Event (3189)

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

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

A siemens customer care center specialist (ccc) reviewed the calibration/adjustment data of immulite 2000 xpi free psa lot 313 from the customer.The adjustments and quality control (qc) data were valid and within expected ranges.A siemens technical application specialist (tas) communicated that the sample was no longer available.Further evaluation of the sample, including testing with heterophilic blocking tubes (hbt), could not be performed.A siemens headquarter support center specialist (hsc) reviewed the data collected by the customer, performed a search of the historic database on 25-mar-2019, and found no additional discordant falsely elevated results complaints for immulite 2000 xpi free psa lot 313.Hsc found that the possibility of interference from heterophilic and/ or non-specific binding antibodies, or sample specific issues could not be excluded.Based on the information provided, the falsely high free psa results are not due to a system or reagent lot issue.Unknown interference in the patient sample is suspected.Immulite 2000 xpi free psa kit lot 313 is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely elevated free prostate-specific antigen (free psa) results were obtained using an immulite 2000 xpi instrument.The initial discordant result was not reported to the physician(s).The sample was repeated in dilution of 1:3, 1:5, and 1:10 of the neat sample.The sample resulted lower than the initial discordant result each time it was diluted.The repeat result obtained with 1:10 dilution was considered to be correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences 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 patients due to the discordant, falsely elevated free psa results.

• 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 4E; UK LL55 4E
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; uk registration #: 3002806944; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer Contact: mardochee timolien ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242503
• MDR Report Key: 8478225
• MDR Text Key: 147171640
• Report Number: 2432235-2019-00118
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P060005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: IMMULITE 2000 FREE PSA
• Device Catalogue Number: L2KPF2
• Device Lot Number: 313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/03/2019
• 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
• Patient Age: 81 YR