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

Model Number	RF621
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) and reported a discordant, falsely depressed cardiac troponin i (tni) patient result was obtained on a dimension exl with lm instrument.Siemens is investigating the event.
Event or Problem Description
A discordant falsely depressed cardiac troponin i (tni) result was obtained on a patient sample on a dimension exl with lm system.The result was reported to the physician(s) who questioned the result.The same sample was repeated with an alternate lot of the cardiac troponin i assay and a higher result, considered correct was obtained.A corrected report was issued.The same patient sample was processed on an alternate dimension exl with lm system.A discordant falsely depressed tni result was obtained with one tni lot and a lower result was obtained with the alternate tni lot.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed cardiac troponin i(tni) result.
Additional Manufacturer Narrative
Siemens headquarters support center (hsc) completed the investigation of the discordant cardiac troponin i (tni) results.Siemens requested the sample from the patient to be returned to siemens for evaluation.The returned patient sample evaluation was conducted and included testing the sample using dimension exl tni reagent lots eb1045, ed0227, and ed0334.The sample was also tested with an alternate siemens troponin i assay.The testing showed that the returned sample resulted with an elevated tni value of 0.273 ng/ml with reagent lot ed0334 and <0.017 ng/ml with reagent lots eb1045 and ed0227.The alternate siemens troponin i assay also gave an elevated result.Hsc concluded that the correct troponin i value for this patient is the lower <0.017 ng/ml result that was obtained with lots eb1045 and ec1071 at the customer site.The siemens internal evaluation included a heterophile antibody screening test that did not detect heterophilic antibodies.While this test can verify the presence of heterophilic antibodies, the results of this test do not indicate heterophilic interference is not present.Hsc concluded that this event is consistent with a patient specific interferent such as a heterophilic antibody, macrotroponin, or autoantibody that is reactive against a unique constituent in reagent lot eb1045, however that interferent cannot be confirmed or further identified with the data available.The cause of the event is unknown, and hsc can perform no further investigation.The customer is operational.The device is performing within specifications.No further evaluation is required.Sections d4 and h4 have been updated to reflect the hsc conclusion that lot ed0334 rather than lot eb1045 gave the discordant results.Section h6 has been updated to reflect the hsc investigation.Original mdr 2517506-2020-00200 was filed 02 jul-2020.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION® TNI CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark, de
• MDR Report Key: 10224496
• Report Number: 2517506-2020-00200
• Device Sequence Number: 19641818
• Product Code: MMI
• UDI-Device Identifier: 00842768022067
• UDI-Public: 00842768022067
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081643
• 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): 08/07/2020

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: 11/29/2020
• Device Model Number: RF621
• Device Catalogue Number: RF621 SMN 10464525
• Device Lot Number: ED0334
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR