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

Model Number	RF521
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) and reported a delay in reporting of a cardiac troponin i (ltni) patient result was obtained on a dimension xpand plus w/hm instrument.Siemens healthcare diagnostics headquarters support center (hsc) is investigating the event.
Event or Problem Description
A delay of reporting a patient result for cardiac troponin i (ltni) occurred on the dimension xpand plus w/hm instrument.The results obtained on the dimension xpand plus w/hm instrument were not reported to the physician.The same sample was tested at an alternate facility with a non-siemens methodology and a negative result was obtained and reported.There are no known reports of patient intervention or adverse health consequences due to the delayed ltni result reporting.
Additional Manufacturer Narrative
Mdr 2517506-2019-00385 was filed on 15-oct-2019.Additional information (11-feb-2020): siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant cardiac troponin i (ltni) results and reporting delay.Hsc evaluated the information provided and the instrument data files.No product non-conformance was identified with either the dimension xpand plus w/hm instrument or the ltni assay.Quality control was within acceptable limits on the date of sample processing.Since the event occurred, no other discrepant sample results for ltni have been observed by this customer.The cause of the isolated event is unknown.Hsc noted that the pattern of obtaining original result of "below assay range" with the diluted sample recovering an unexpected value and the alternate technology yielding different results, is typical of a sample containing a heterophilic antibody causing non-specific binding.As stated in the instructions for use (ifu) for the dimension ltni assay, "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.Section h6 has been updated to reflect the hsc investigation.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION® LTNI CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; p.o. box 6101; newark DE 19714 6101
• MDR Report Key: 9194572
• Report Number: 2517506-2019-00385
• Device Sequence Number: 13913357
• Product Code: MMI
• UDI-Device Identifier: 00842768013904
• UDI-Public: 00842768013904
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K010313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

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: 03/18/2020
• Device Model Number: RF521
• Device Catalogue Number: SMN 10444896
• Device Lot Number: FB0078
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1