MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION® EXL WITH LM INTEGRATED CHEMISTRY SYSTEM; CARDIAC TROPONIN I CALIBRATOR

Catalog Number RC421C SMN10444986

Device Problems Use of Device Problem (1670); Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2016

Event Type  malfunction  

Manufacturer Narrative

The cause of the biased low qc and patient results is user error.The root cause of the issue was the customer was using an inappropriate calibrator for the dimension exl troponin i method.The customer had been calibrating the dimension exl tni method with an incorrect calibrator (dimension clinical chemistry system heterogenous immunoassay module ctni calibrator) rather than the correct calibrator (dimension exl loci troponin i calibrator).Patients results in the instrument data that had been calibrated with the incorrect calibrator were recalculated.Only one sample showed a result above 0.056 ng/ml that was reported with tni of <0.056 ng/ml.The sample id was (b)(6) from (b)(6) and a 0.048 ng/ml was reported from the rxl calibration but it is showing as a 0.060 ng/ml with a loci calibrator calibration.The dimension exl troponin i method instructions for use indicates that the range encompassing the 99th percentile of normal patient results is 0.000 - 0.056 ng/ml.All other samples produced clinically concordant results when recalculated using a calibration from the correct calibrator.Based upon the instrument data, the effect of using the rxl calibrator with the loci method resulted in a depression of the result between 8 to 39 %.On 08/10/2016 the siemens technical applications specialist (tas) reviewed calibrations due to tni not auto accepting.The customer discovered that they had purchased the rxl ctni calibrator (rc421c) instead of loci tni (rc621).All calibrations that had not auto accepted had failed standard deviation (sd) for one or more levels but were accepted manually.The issue was resolved by recalibration of the ctni method with the appropriate calibrator set and customer education.The device is performing within specifications.No further evaluation of the device is required.

Event Description

Biased low troponin i (tni) results were obtained on qc and patient samples during a period from (b)(6) 2016 through (b)(6) 2016 after an incorrect calibrator set had been used to calibrate the tni method.Qc remained within laboratory ranges and patient results were reported to the physicians.After the calibration error was identified, patient and qc samples were recalculated and higher results were obtained.There is no indication that patient treatment was altered or prescribed on the basis of biased low troponin i results.There was no report of adverse health consequences as a result of the biased low troponin i results.

• Brand Name: DIMENSION® EXL WITH LM INTEGRATED CHEMISTRY SYSTEM
• Type of Device: CARDIAC TROPONIN I CALIBRATOR
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 5932123
• MDR Text Key: 54042677
• Report Number: 2517506-2016-00318
• Device Sequence Number: 1
• Product Code: JIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 12/01/2016
• Device Catalogue Number: RC421C SMN10444986
• Device Lot Number: 5LD063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2015
• 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