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

Model Number ADVIA 560 HEMATOLOGY SYSTEM

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2022

Event Type  malfunction  

Event Description

Discordant, falsely elevated hemoglobin (hgb), mean corpuscular hemoglobin (mch), and mean corpuscular hemoglobin concentration (mchc) results were obtained on a patient sample on an advia 560 hematology system.The discordant results were not reported to the physician(s).The following day, a new sample from the same patient was run for for hgb, mch, and mchc on the advia 560 hematology system as well as on a non-siemens analyzer.The results on the advia 560 hematology system again recovered falsely elevated, and the results obtained on the non-siemens analyzer recovered lower.The lower results obtained on the non-siemens analyzer were reported, as the correct results, to the physician(s).Due to the one day delay in obtaining the correct hgb result, there was a delay in performing a blood transfusion for the patient.There are no known reports of adverse health consequences due to the discordant hgb, mch, and mchc results, or due to the delay in performing the blood transfusion.

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.A system self test was performed and passed acceptably.Siemens is investigating the issue.Mdr 2432235-2022-00187 was filed for the discordant results obtained on (b)(6) 2022.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2022-00186 on 17-jun-2022.Additional information (20-jun-2022): subsequent to the initial medical device report (mdr) filed on 17-jun-2022, siemens learned from the customer that the patient expired due to non-response of the medication (not because of the siemens test results).In fact, many of the siemens test results on may 18 and 19, 2022 reported in section b5 of the initial mdr were flagged and, as per the advia 560 hematology system operator's guide, the customer repeated the tests.A blood transfusion was performed based on the non-siemens system results.Per siemens' advia 560 hematology system operator's guide, a white blood cell (wbc) count >75 x 10^3 cells/ul is listed to have known interferences with red blood cell (rbc) count, mean corpuscular volume (mcv) and hemoglobin.This patient's wbc was reported as 138 x 10^3 cells/ul.The system is performing according to specifications.No further evaluation of this device is required.The investigation findings and investigation conclusions codes in section h6 were updated to reflect this information.Supplemental mdr 2432235-2022-00187_s1 was also filed for this additional information.

• Brand Name: ADVIA 560 HEMATOLOGY SYSTEM
• Type of Device: ADVIA 560 HEMATOLOGY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): DIATRON MI PIC; registration #: 3009297077; tablas str. 39; budapest, H-109 7; HU H-1097
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 14734513
• MDR Text Key: 301935051
• Report Number: 2432235-2022-00186
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00630414601816
• UDI-Public: 00630414601816
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K112755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA 560 HEMATOLOGY SYSTEM
• Device Catalogue Number: 11170842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1