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

Model Number N/A

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2023

Event Type  malfunction  

Manufacturer Narrative

An outside united states (ous) customer contacted a siemens customer care center to report a falsely elevated psa result obtained on a patient sample on an immulite 2000 instrument.The erroneous result was reported to the physician(s), who questioned the result.The sample was repeated on an alternate advia centaur xp instrument.The repeat result was lower than the erroneous result.The repeat result was reported, as the correct result, to the physician(s).The limitations section of the immulite 2000 psa instructions for use (ifu) states: "serum psa concentrations should not be interpreted as absolute evidence for the presence or absence of malignant disease, nor should serum psa be used alone as a screening test for malignant disease.Prediction of malignant prostatic disease recurrence should be based on a complete clinical evaluation of the patient, which may also include serial serum psa determinations.Samples should be obtained before biopsy, prostatectomy or prostatic massage, since manipulation of the prostate gland may lead to elevated psa levels persisting up to 3 weeks." siemens does not claim equivalency between immulite 2000 and advia centaur xp.Siemens is investigating.This ous product (catalog number 10380986, as listed in d4) is associated with similar product in the united states: catalog number 10706281 / premarket approval (pma)# p930027.Common device name: total, prostate specific antigen(noncomplexed & complexed) for detection of prostate cancer.

Event Description

A falsely elevated psa result was obtained on a patient sample on an immulite 2000 instrument.The erroneous result was reported to the physician(s), who questioned the result.The sample was repeated on an alternate advia centaur xp instrument.The repeat result was lower than the erroneous result.The repeat result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated psa result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2023-00178 on 25-august-2023.Additional information 28-september-2023: an outside united states (ous) customer reported a falsely elevated psa result on a 65-year-old male with postoperative prostate cancer on their immulite 2000 system with psa lot 439.The sample result was 0.21 ng/ml and upon repeat on alternate method (advia centaur xp) it was 0.03 ng/ml and accepted by the physician.Siemens reviewed the customer's adjustment and quality control (qc) data.Adjustment and qcs were valid and within package insert ranges.The sample could not be sent to siemens for further testing and evaluation.The customer ran a precision study with this patient sample and with an alternate patient sample with psa lot 439.The patient in question had a high coefficient of variation, while the other patient sample precision was within the immulite 2000 psa instructions for use (ifu) precision limits.This indicates that the issue is not system or lot specific but isolated to this patient sample.The customer is operational.Immulite 2000 psa lot 439 is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.In section h6, the investigation findings and investigation conclusions codes were updated.

• Brand Name: IMMULITE 2000 PSA
• Type of Device: PSA IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; gwynedd, llanberis LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer Contact: karen confort ; 333 coney st.; east walpole, MA 02032 ; 3392069063
• MDR Report Key: 17623972
• MDR Text Key: 321956775
• Report Number: 1219913-2023-00178
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P930027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 10380986
• Device Lot Number: 439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1