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	10/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding a discordant falsely elevated total prostate specific antigen (tpsa) patient sample result obtained on a dimension exl with lm system.Siemens is investigating the event.Mdr 2517506-2021-00330 was filed for the same event.
Event or Problem Description
A discordant falsely elevated total prostate specific antigen (tpsa) result was obtained on a patient sample processed on a dimension exl with lm system.The discordant result was reported to the physician(s) who questioned the result.The same sample was reprocessed on an alternate, non-siemens system and a lower result, considered correct, was obtained.A corrected report ws issued.The customer stated the patient had a urology biopsy performed (date not provided).There are no known reports of adverse health consequences due to the discordant falsely elevated tpsa result or the biopsy procedure.
Additional Manufacturer Narrative
Additional information (07-feb-2022): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the information provided by the customer.Hsc requested the patient sample to be sent to siemens for internal investigation.The customer was not able provide the patient sample to siemens for internal investigation.The discordant elevated total prostate specific antigen (tpsa) result was consistent with a heterophile or non-specific binding which can cause false high results.The customer continues to use the dimension exl w/lm system without any issues with other patient tpsa samples.The event reported was a patient specific issue.Hsc has not identified a potential product issue with the tpsa assay.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2517506-2021-00329 was filed 23-nov-2021.Mdr 2517506-2021-00330 was filed for the same event.Mdr 2517506-2021-00330 supplement 1 is filed for the same event.

• 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 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: james morgera ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 12860287
• Report Number: 2517506-2021-00329
• Device Sequence Number: 4353182
• Product Code: MTF
• UDI-Device Identifier: 00842768013874
• UDI-Public: 00842768013874
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P000021/S023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2022

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: 06/28/2022
• Device Model Number: 10444889
• Device Catalogue Number: RF451 SMN 10444889
• Device Lot Number: BA2179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown