MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE

Model Number	10444896
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A discordant falsely elevated cardiac troponin-i (ltni) patient sample result was obtained on a dimension xpand plus with hm system.The falsely elevated result was reported to the physician(s).The falsely elevated result was obtained on a plasma sample (lithium heparin) of the patient sample draw.A serum sample from the same patient draw was processed on the next day on the same dimension xpand plus with hm system.A lower result was obtained and considered correct.A corrected report was issued.Serial troponin testing was also done at an alternate facility, on a non-siemens system using an alternate methodology for troponin.Lower results were obtained.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated ltni patient result.
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely elevated cardiac troponin-i (ltni) patient sample result obtained on a dimension xpand plus with hm system.The falsely elevated result was obtained on a plasma sample (lithium heparin) of the patient sample draw.Siemens healthcare diagnostics inc.Had previously investigated the event of discordant falsely elevated result with cardiac troponin-i (ltni) on the dimension xpand plus with hm system with lot ea2314.Siemens had confirmed that dimension cardiac troponin-i (ltni) lot ea2314 shows a positive bias with lithium heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/ml [0.07 ug/l].Troponin values as high as 0.20 ng/ml [0.20 ug/l] had been observed with lithium heparin plasma that are expected to be within the 99th percentile.Serum samples collected from normal, healthy individuals whose results fall within the reference interval or below the 99th percentile of 0.07 ng/ml [0.07 ug/l] were not impacted by this issue.Urgent medical device correction, dc-22-02.A.Us dated may 18, 2022 and urgent field safety notice dc-22-0-02.A.Ous dated may-2022 were sent to all customers who had been shipped dimension cardiac troponin-i (ltni) lot ea2314.Siemens recommended that customers use serum patient samples only when processing samples with ltni lot ea2314.Customers were instructed to discard ltni lot ea2314 if their laboratory is not able to use serum samples.The customer processed a serum sample of the patient as recommended in the urgent medical device correction, dc-22-02.A.Us and obtained a correct result.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® CARDIAC TROPONIN I 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: 14851486
• Report Number: 2517506-2022-00168
• Device Sequence Number: 14045065
• Product Code: MMI
• UDI-Device Identifier: 00842768013904
• UDI-Public: 00842768013904
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K010313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/29/2022

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: 11/10/2022
• Device Model Number: 10444896
• Device Catalogue Number: RF521 SMN 10444896
• Device Lot Number: EA2314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2517506-05/24/2022-002-C
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Female