MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. EMIT 2000 DIGOXIN ASSAY

Model Number	EMIT 2000 DIGOXIN ASSAY
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens healthcare diagnostics inc.(siemens) field service engineer (fse) was dispatched to the customer site to determine the cause of the internal quality control recovering out of range.From the achieve files, siemens calculated the average internal quality control for level 1 and 2 and determined that they were both below the target range: internal qc level 1 recovered at 0.43 ng/ml and internal qc level 2 recovered at 1.40 ng/ml.The fse performed a system fill, reagent probe accuracy and abs check.The abs test results recovered within specifications of %cv<1.0.To troubleshoot the issue, the fse performed a 10 fold measurement with the digoxin calibrator and internal quality control level 1 measurement mean from the 10 fold measurement recovered below assay lower range (0.3 ng/ml)and below the instruction for use (ifu) target range (0.47 - 0.71 ng/ml).Internal quality control level 2 measurement mean from the 10 fold measurement recovered below the ifu target range (1.42 - 1.92 ng/ml).As of july 21, 2017, the customer indicated that the quality controls are increasing and recovering well.The cause of the internal quality controls recovering out of range is unknown.The customer incorrectly ran patient samples when internal quality controls recovered out of range.Based on the emit 2000 digoxin assay, "if any control result is not within the established control limits, despite repeat testing or recalibration, call for technical assistance.Once you have validated the calibration curve, run patient samples".Furthermore, the incorrect instrument setting for the assay range was shown on the analyser.Based on the customer's viva-e analyser folder files, the low concentration was set to 0.2 ng/ml.Based on the application sheet "rev.Vdig.7 2012-02-27 msw: 545q-us" and digoxin ifu, the assay range is 0.3 - 5 ng/ml and the "low concentration" has to be set to 0.3 ng/ml." the testing of patient samples while qc is out of range is a user error.The instrument and reagents are performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Digoxin results were obtained for 2 patient samples when the internal quality controls (qc) recovered out of range on the viva-e analyser.These results were expected for these patient and not questioned by the physician(s).The qc range was 0.47 - 0.71 ng/ml for biorad liquicheck level 1 (lot 27711) and 1.42 - 1.92 ng/ml biorad liquicheck level 2 (lot 27712).On the day of the event, internal qc recovered 0.43 ng/ml for level 1 and 1.41 ng/ml for level 2.Upon duplication, the internal qc recovered 0.52 ng/ml for level 1 and 1.46 ng/ml for level 2.It is unknown if other patient samples were run while the internal qc recovered out of range.There are no known reports of patient intervention or adverse health consequences due to the customer running patient samples while internal qc recovered out of range.

• Brand Name: EMIT 2000 DIGOXIN ASSAY
• Common Device Name: EMIT 2000 DIGOXIN ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 6746852
• Report Number: 2517506-2017-00610
• Device Sequence Number: 881430
• Product Code: KXT
• UDI-Device Identifier: 00842768000966
• UDI-Public: 00842768000966
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K951755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2017

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: 04/06/2018
• Device Model Number: EMIT 2000 DIGOXIN ASSAY
• Device Catalogue Number: 10445315
• Device Lot Number: J2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2017
• Initial Report FDA Received Date: 07/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1