MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 560 HEMATOLOGY SYSTEM

Model Number	ADVIA 560 HEMATOLOGY SYSTEM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer did not report any discrepant results with other patient samples being run on the advia 560 hematology system on the same day as the reported discrepant sample.The customer contacted a siemens customer care center (ccc).Siemens is continuing to investigate the cause for the discrepant results for this single patient.It is not clear to siemens why the patient received a blood transfusion.It is estimated that hgb results < 1.7 g/dl are not compatible with life.
Event or Problem Description
Discordant, falsely low hemoglobin (hgb) results were obtained on a patient sample on an advia 560 hematology system.The patient sample was run for hgb, as part of a complete blood count (cbc), four times on the affected advia 560 hematology system.Hgb recovered falsely low all four times.The patient was redrawn and was run using the same sample id for hgb, as part of a cbc, three additional times on the affected advia 560 hematology system and continued to recover falsely low.The results of the seven cbcs were reported to the physician(s).Due to the false low hgb results, the patient received a blood transfusion.The customer sent the sample to an alternate laboratory and the hgb test was repeated on an unknown system, recovering higher.The alternate test result was considered to be the correct result and a corrected report was reported to the physician.The customer did not allege any discordant results of the other cbc parameters obtained on the advia 560 hematology system.There are no known reports of adverse health consequences due to the discordant, falsely low hemoglobin (hgb) results and the subsequent transfusion.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2021-00149 on 18-jun-2021.Additional information (30-jun-2021): quality controls (qc) recovered in range on both the day before the event as well as the day of the event.Additional information (12-jul-2021): siemens investigation determined that pre-analytical variables and sample specific issues cannot be ruled out as possible causes of the event.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA 560 HEMATOLOGY SYSTEM
• Common Device Name: ADVIA 560 HEMATOLOGY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 12026241
• Report Number: 2432235-2021-00149
• Device Sequence Number: 4269232
• Product Code: GKZ
• UDI-Device Identifier: 00630414601816
• UDI-Public: 00630414601816
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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 Model Number: ADVIA 560 HEMATOLOGY SYSTEM
• Device Catalogue Number: 11170842
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR