MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION®; DIMENSION® LOCI CARDIAC TROPONIN I CALIBRATOR

Model Number	10464336
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) about a falsely elevated cardiac troponin i (tni) result obtained on a dimension exl with lm instruments.Siemens headquarters support center (hsc) completed the investigation of the event.A review of the calibration performed on 16-apr-2020 showed shifts in the reaction signal that indicate there was a potential issue with the storage or handling of the calibrator causing the shift in quality control and patient performance.The cause of the elevated troponin with samples and qc was an issue with the calibration on 16-apr-2020 which was resolved with the calibration performed on 17-apr-2020 on the original instrument dimension exl s/n (b)(4).There is no evidence of a product non-conformance.The customer is operational.The system is operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
Discordant, falsely elevated cardiac troponin i (tni) results were obtained on patient samples on a dimension exl with lm instrument.The discordant results were reported to the physician when out of range daily quality control (qc) was noted.The same samples were reprocessed the same day or the next day on the same instrument as well as on an alternate dimension instrument, lower correct results were obtained.Corrected results were reported.There are no known reports of patient intervention or adverse health consequences due to the discordant tni results.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® LOCI CARDIAC TROPONIN I CALIBRATOR
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; p.o. box 6101; newark, de
• MDR Report Key: 10045167
• Report Number: 2517506-2020-00150
• Device Sequence Number: 3867503
• Product Code: JIT
• UDI-Device Identifier: 00842768022074
• UDI-Public: 00842768022074
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130276
• 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
• Report Date (Section B): 05/11/2020

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: 10/01/2020
• Device Model Number: 10464336
• Device Catalogue Number: RC621 SMN 10464336
• Device Lot Number: 9MD044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1