MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION; DIMENSION® (TPSA) TOTAL PROSTATE SPECIFIC ANTIGEN FLEX® REAGENT CARTRIDGE

Model Number	10444889
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2517506-2021-00139 was filed for the same event.The customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding a discordant elevated total prostate specific antigen (tpsa) result obtained on a patient sample on a dimension exl w/lm system.Siemens is investigating the event.
Event or Problem Description
A discordant elevated total prostate specific antigen (tpsa) result was obtained on a patient sample on a dimension exl w/lm system.The discordant result was reported to the physician.The same sample was reprocessed on an alternate non-siemens system and a lower result was obtained.No corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the discordant elevated tpsa result.
Additional Manufacturer Narrative
Initial mdr 2517506-2021-00141 was filed 16-jun-2021.Mdr 2517506-2021-00139 was filed for the same event.Correction section a1: patient identifier unknown.Additional information (12-jul-2021): siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant falsely elevated total prostate specific antigen (tpsa) result on a dimension exl with lm system.Hsc has reviewed the instrument data.No product non-conformance with the assay reagent or analyzer was identified.Hsc has received the heterophile blocking tube (hbt) results from the customer which shows that the results are consistent with at least some heterophile antibody interference.The customer performed the heterophile blocking test procedure rather than send the sample back to siemens.The dimension total prostate specific antigen (tpsa) instructions for use (ifu) states under limitations of procedure: "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay has been designed to minimize interference from heterophilic antibodies.Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed.A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution." the device is performing within specifications.No further evaluation is required.Mdr 2517506-2021-00139 supplement 1 was filed for the same event.Section h6 has been updated to reflect the hsc investigation.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION® (TPSA) TOTAL PROSTATE SPECIFIC ANTIGEN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19614 6101
• MDR Report Key: 12009246
• Report Number: 2517506-2021-00141
• Device Sequence Number: 844758
• Product Code: MTF
• UDI-Device Identifier: 00842768013874
• UDI-Public: 00842768013874
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000021/S002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2021
• Device Model Number: 10444889
• Device Catalogue Number: RF451 SMN 10444889
• Device Lot Number: FA1292
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR