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

Model Number 10464336

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2020

Event Type  malfunction  

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 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®
• Type of Device: DIMENSION® LOCI CARDIAC TROPONIN I CALIBRATOR
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; p.o. box 6101; newark, de
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark, de
• Manufacturer Contact: james morgera ; 500 gbc drive; p.o. box 6101; newark, de ; 6318356
• MDR Report Key: 10045167
• MDR Text Key: 195657380
• Report Number: 2517506-2020-00150
• Device Sequence Number: 1
• Product Code: JIT
• UDI-Device Identifier: 00842768022074
• UDI-Public: 00842768022074
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/29/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1