MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER

Model Number	ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
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	07/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics inc.(siemens) analysed the data logs from the advia 2120i hematology system with single aspirate autosampler.The data logs provided by the customer were not legible and siemens requested for additional data, in which the customer has not provided.The internal quality control was checked and recovered within range.The cause of the discordant hemoglobin result is unknown.The customer validated the hemoglobin result when the advia 2120i hematology system with single aspirate autosampler flagged the complete blood count (cbc) and when the affected hemoglobin result recovered outside of the customer normal reference range of 133-180 grams/liter.The advia® 2120i hematology systems operator's guide indicates that "morphology flags are plus signs (+) displayed in the review/edit tab and the run screen.These flags, one to three plus signs, alert the operator to possible cellular conditions that may require additional laboratory attention, such as preparing a slide for microscopic examination" and "whenever morphology or quantitative flags are triggered, the laboratory, before reporting patient results, must validate the results and take the appropriate action in accordance with established standard operating procedures." the affected patient sample was re-run and recovered comparably with the results obtained from the re-drawn sample.The instrument and reagent(s) are performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A flagged discordant, falsely low hemoglobin (hgb) result was obtained on one patient sample on the advia 2120i hematology system with single aspirate autosampler.The hgb result recovered outside of the customer normal reference range and the system flagged the complete blood count (cbc).The hgb result was validated by the customer and reported to the physician, who questioned the result.The patient blood was re-drawn after he was admitted into the hospital and run on an alternate advia 2120i hematology system.The repeated result on the alternate system recovered higher.The original patient sample was re-run, resulting similar to the result from the re-drawn sample.The corrected result was provided to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low hgb result.

• Brand Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
• Common Device Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 6745191
• Report Number: 2432235-2017-00440
• Device Sequence Number: 11071830
• Product Code: GKZ
• UDI-Device Identifier: 00630414581965
• UDI-Public: 00630414581965
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K102644
• 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): 07/26/2017

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 Model Number: ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10488923
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 07/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR