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

Model Number	ADVIA 2120I (ROHS) HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens healthcare diagnostics inc.(siemens) customer service engineer (cse) was dispatched to customer site.The cse replaced the signal processor printed circuit board (pcb) and monitored the advia 2120i system.The cse indicated that several hundred samples were run on the affected advia 2120i (rohs) hematology system with single aspirate auto sample without any issues.Upon further investigation the sample results provided by the customer did not portray any flags or unbelievable results.Although the cse replaced the signal processor printed circuit board (pcb), there was no evidence of an instrument malfunction from the data provided by the customer.The cause of the discordant, falsely low plt result and falsely elevated hct result, is unknown.The instrument and reagents are performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely low platelet (plt) result and a discordant, falsely elevated hematocrit (hct) result were obtained on a patient sample on the advia 2120i (rohs) hematology system with single aspirate autosampler.The discordant results were not reported to the physician.The same sample was re-run on the same system 3 times and on an alternate advia 2120i system 4 times.Upon repeat, the platelet results recovered higher, while the hematocrit result recovered lower.The corrected results from the alternate advia 2120i system were provided to the physician.The internal quality controls recovered within range when the discordant results were obtained.There are no reports of patient intervention or adverse health consequence due to the discordant low platelet (plt) and discordant elevated hematocrit (hct) results.

• Brand Name: ADVIA 2120I (ROHS) HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
• Common Device Name: ADVIA 2120I (ROHS) HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 6732478
• Report Number: 2432235-2017-00433
• Device Sequence Number: 19052942
• Product Code: GKZ
• UDI-Device Identifier: 00630414019789
• UDI-Public: 00630414019789
• 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): 07/21/2017

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 (ROHS) HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 11219530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2017
• Initial Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR