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

Model Number	10444905
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens healthcare diagnostics representative from the reagent manufacturing technical operations department observed a bias in result recoveries during an internal study with cardiac troponin-i (ctni) lot ba3088 on the dimension® rxl max® integrated chemistry system.Siemens is investigating the event.
Event or Problem Description
During an internal investigation, siemens reagent manufacturing technical operations observed a bias in result recoveries with cardiac troponin-i (ctni) lot ba3088 on a dimension® rxl max® integrated chemistry system.The issue was identified in an internal study.No patient results were reported to physicians.There has been no reported customer impact.
Additional Manufacturer Narrative
Additional information (20-sep-2022): siemens healthcare diagnostics inc.Previously implemented a field correction (dc-22-02.A.Us) on may 18, 2022, for certain lots of dimension cardiac troponin i (ltni and ctni).Ctni lot ba3088 shares the same raw material as the lots noted in the initial field correction and the initial mdr was filed for lot ba3088 conservatively based upon an internal investigation.Siemens healthcare diagnostics inc.Has confirmed a positive bias with lithium heparin plasma patient samples with dimension® cardiac troponin i ctni flex® reagent cartridge lot ba3088 on the dimension® rxl max® integrated chemistry system.Lithium heparin plasma patient samples from individuals that are expected to be below the 99th percentile of 0.07 ng/ml [0.07 g/l] were observed to have a positive bias.Troponin values as high as 0.21 ng/ml [0.21 g/l] have 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 g/l] were not impacted by this issue.Urgent medical device correction dc-22-02.B.Us dated september 22, 2022 and urgent field safety notice dc-22-02.B.Ous dated september 2022 were sent to all customers who had been shipped the cardiac troponin-i (ctni) lot ba3088.Siemens recommended that customers use serum patient samples only when processing samples with ctni lot ba3088.Customers were instructed to discard ctni lot ba3088 if they are unable to use serum patient samples for testing.Section h6 has been updated to reflect siemens' investigation.Initial mdr 2517506-2022-00221 was filed on 15-aug-2022.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® CTNI 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: 15225933
• Report Number: 2517506-2022-00221
• Device Sequence Number: 5602587
• Product Code: MMI
• UDI-Device Identifier: 00842768013836
• UDI-Public: 00842768013836
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2022

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
• Device Expiration Date: 03/29/2023
• Device Model Number: 10444905
• Device Catalogue Number: RF421C SMN 10444905
• Device Lot Number: BA3088
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• 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: Initial
• 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 Sex: Unknown