MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH VANCOMYCIN (VANC)

Model Number	ATELLICA CH VANCOMYCIN (VANC)
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens customer care center (ccc).The ccc reviewed the calibration data and observed that a calibration, which failed to recover within auto-acceptance limits, was manually accepted by the operator.Quality control results following the calibration never recovered within acceptable ranges.The ccc conducted normal troubleshooting with the operator.The ccc was notified that the method was calibrated with previously opened drug ii calibrator material.The operator was unaware of the stability of the material.The operator was requested to repeat the calibration with fresh calibrator material.The calibration curve recovered within conformance and quality control material recovered within acceptable ranges.Siemens headquarters support center hsc) further reviewed the instrument files provided by the customer to further confirmed the findings of the ccc.No other issues have been reported by the customer and the service actions performed resolved the reported issue.The instrument is performing within specification.No further evaluation of the device is required.
Event or Problem Description
One discordant, falsely depressed vancomycin (vanc) result was obtained using atellica ch 930 module.The initial result was obtained while the quality control (qc) was outside of ranges and were reported to the physician(s).The initial result was flagged by the atellica ch 930 module.The sample was repeated using another atellica ch 930 module.The repeat result was considered correct and reported to the physician(s).

• Brand Name: ATELLICA CH VANCOMYCIN (VANC)
• Common Device Name: ATELLICA CH VANCOMYCIN (VANC)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 9365627
• Report Number: 2432235-2019-00434
• Device Sequence Number: 11320360
• Product Code: LEH
• UDI-Device Identifier: 00630414596020
• UDI-Public: 00630414596020
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K161954
• 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): 11/22/2019

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: 06/30/2020
• Device Model Number: ATELLICA CH VANCOMYCIN (VANC)
• Device Catalogue Number: 11097511
• Device Lot Number: 190146
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1