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

Model Number	ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that a discordant white blood cell count (wbc) result was obtained on a patient sample on the advia 2120i hematology system with dual aspirate autosampler.The customer reported that a sample with elevated wbc was processed prior to the affected sample and the customer indicated that there was evidence of carryover.Siemens reviewed the event and was unable to eliminate a sample integrity issue or other pre-analytical variables as contributing factors to the discordant result.The customer did not provide additional information.The cause of the discordant wbc result is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that a discordant white blood cell count (wbc) result of 5,400 was obtained on a patient sample on an advia 2120i hematology system with dual aspirate autosampler.The discordant result was reported to the physician(s), who questioned the result.The sample was repeated on two alternate advia 2120 hematology systems; the repeat results were either 340 and 400 or 340,000 and 400,000.The customer reported that the correct result was reported to the physician(s), but did not indicate which result was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant wbc result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2018-00443 on 20-nov-2018.Additional information (27-nov-2018): the customer provided the unit used for the results mentioned in the initial mdr; the unit for the white blood cell count (wbc) results is 10e3/ul.The customer reported that the repeat results were the correct results and that the initial system was used to confirm the correct results.Additionally, the customer reported that patient care was impacted, but did not provide additional details regarding the impact to patient care.The customer indicated that they observe the carryover issue when samples with a wbc result of greater than (b)(4) are processed, but did not provide additional data.Corrected information (27-nov-2018): the initial mdr mentioned that the initial sample was repeated to obtain the repeat results.The customer clarified that the repeat results were obtained using a different sample from the patient.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2018-00443 on 20-nov-2018 and the initial supplemental mdr on 21-dec-2018.Corrected information (24-jan-2019): the customer reported that the alternate systems, used to obtain the correct results, were advia 2120i hematology systems with dual aspirate.The customer clarified that the discordant result was 5.40 x 10e3/ul and that the repeat results were 340 x10e3/ul and 400 x 10e3/ul.There was no impact to patient treatment as the physician(s) questioned the discordant result and the patient underwent a bone marrow transplant.Additional information (24-jan-2019): the patient has a history of leukopenia due to ablative chemotherapy.Sections b5, b6, and b7 were updated to reflect the additional and corrected information.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that a discordant, falsely low white blood cell count (wbc) result of 5.40 x 10e3/ul was obtained on a patient sample on an advia 2120i hematology system with dual aspirate autosampler.The discordant result was reported to the physician(s), who questioned the result.The sample was repeated on two alternate advia 2120i hematology systems with dual aspirate, resulting higher.The customer reported that the correct result was reported to the physician(s), but did not indicate which result was reported to the physician(s).There are no known reports of adverse health consequences due to the discordant, falsely low wbc result.

• Brand Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Common Device Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 8089872
• Report Number: 2432235-2018-00443
• Device Sequence Number: 19197300
• Product Code: GKZ
• UDI-Device Identifier: 00630414560045
• UDI-Public: 00630414560045
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K162977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2019

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 DUAL ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10285573
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 11/27/2018; 01/24/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 12/21/2018; 02/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1