MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. EMIT AMIKACIN ASSAY

Model Number	EMIT AMIKACIN ASSAY
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted a siemens customer care center.The customer identified and confirmed that the calibrator levels 5 and 6 for the emit amikacin assay were mislabeled by the customer and was used to calibrate the assay.After obtaining the discordant results, the operator subsequently properly labelled the calibrators and prepared new calibration to obtain acceptable calibration.Mislabeling of calibrators was a use error.The reagent and instrument are performing according to specifications.No further evaluation of these devices is required.
Event or Problem Description
A patient sample was initially processed for amikacin on an atellica ch 930 analyzer using the emit amikacin assay, and the sample recovered 50 ug/ml.The initial result was considered discordant and was reported to the physician(s).The sample was manually diluted using the level 0 calibrator and repeated twice on the same instrument and the sample recovered lower.The repeat results were not reported to the physician.The customer indicated that they sent a recommendation to recollect the sample as the affected sample was not sufficient for retesting.The correct result for this patient is unknown and the customer does not recall whether the patient was redrawn.There are no known reports of patient intervention or adverse health consequences due to the discordant amikacin result(s).

• Brand Name: EMIT AMIKACIN ASSAY
• Common Device Name: EMIT AMIKACIN ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark NJ 19714 6101
• Manufacturer Contact: christina lam ; 511 benedict avenue; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 12961443
• Report Number: 2517506-2021-00338
• Device Sequence Number: 5424087
• Product Code: KLQ
• UDI-Device Identifier: 00842768001543
• UDI-Public: 00842768001543
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K822657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2021

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: 10/29/2023
• Device Model Number: EMIT AMIKACIN ASSAY
• Device Catalogue Number: 10445383
• Device Lot Number: N2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Unknown