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

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/22/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) and reported that they obtained falsely elevated platelet recovery on a national external quality control assurance scheme (neqas) test on an advia 2120i hematology system with single aspirate autosampler.The customer also reported that quality controls (qcs) were recovering acceptably and that platelet results obtained on patient samples were over recovering on the system.Due to this, the customer recalibrated the system and a lower rate of over recovering platelet results was obtained.Siemens reached out to the customer with questions regarding the affected patient samples; however, the customer has not responded thus far.Siemens is investigating the issue.

Event Description

The customer reported that there was an over recovery of platelet results obtained on patient samples on an advia 2120i hematology system with single aspirate autosampler.The samples were repeated after the customer recalibrated the system, and a lower rate of over recovering platelet results was obtained.It is unknown if any of these results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the over recovering platelet results on patient samples.

Manufacturer Narrative

Siemens filed the initial mdr on 08-nov-2018.Additional information (12-nov-2018): the customer reported that higher platelet results were obtained on the advia 2120i hematology system with single aspirate autosampler, compared to the platelet results obtained on another instrument at their other laboratory.The platelet results obtained on the advia 2120i hematology system with single aspirate autosampler were reported to the physician(s) and the physician(s) did not question the results.Corrected information (12-nov-2018): the initial mdr indicated that "the samples were repeated after the customer recalibrated the system, and a lower rate of over recovering platelet results was obtained." the customer clarified that they did not repeat the samples tested at their site.They repeated the samples that were sent from their other laboratory to compare the platelet results.Siemens is investigating the issue.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2018-00418 on 08-nov-2018, the first supplemental mdr on 27-nov-2018, and the second supplemental mdr on 07-mar-2019.Corrected information (20-mar-2019): the date in section g4 and section h10 of the second supplemental mdr was 15-feb-2019.The correct date is 05-nov-2018 as the siemens customer service engineer (cse) calibrated and reset the red blood cells optics on (b)(6) 2018.The date in section g4 of this report cannot be updated to reflect the corrected information as this is a required field for this report.The instrument is performing according to specifications.No further evaluation of this device is required.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2018-00418 on 08-nov-2018 and the initial supplemental mdr was filed on 27-nov-2018.Additional information (15-feb-2019): a siemens customer service engineer (cse) was dispatched to the customer's site.The cse recalibrated and reset the red blood cell optics, which resolved the issue.The result code and conclusion code in section h6 were updated to reflect the additional information.The instrument is performing according to specifications.No further evaluation of this device is required.

Manufacturer Narrative

Siemens filed mdr 2432235-2018-00418 on 08-nov-2018, the first supplemental report on 27-nov-2018, the second supplemental report on 07-mar-2019, and the third supplemental report on 26-mar-2019.Additional information (01-oct-2019): it has been observed that platelet (plt) results were over-recovering on whole blood samples and that the plt calibration factor was higher than normal.This was happening when the setpoint calibrator and testpoint controls were recovering the target value provided in the package insert.Siemens determined that this behavior can be resolved by performing the following routine troubleshooting actions: installing a new optics bench and signal processor pcba090, realigning the optics bench, and/or standardizing the system with a new lot of optipoint and recalibrating with a new setpoint lot.Siemens thoroughly investigated the issue and determined that all components (advia 120/2120 optipoint 4x6.0ml, optical assembly rbc/baso/retic, and signal processor pcba-sipr-spare) that could potentially impact plt results over-recovery are performing according to specifications.Siemens personnel were able to resolve the issue using routine troubleshooting procedures related to the optipoint, optical assembly rbc/baso/retic, and/or signal processor pcba-sipr-spare.Siemens could not reproduce nor confirm the issue reported by the customer and no issues were found with the advia 120/2120 optipoint material, the optical assembly for rbc/baso/retic, nor with the signal processor pcba that could not be resolved via routine troubleshooting procedures.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
• Type of Device: ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 8053437
• MDR Text Key: 128595418
• Report Number: 2432235-2018-00418
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00630414581965
• UDI-Public: 00630414581965
• Combination Product (y/n): N
• PMA/PMN Number: K162977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/02/2019

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
• Device Operator: Health Professional
• Device Model Number: ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10488923
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2018
• Initial Date FDA Received: 11/08/2018
• Supplement Dates Manufacturer Received: 11/12/2018; 02/15/2019; 03/20/2019; 10/01/2019
• Supplement Dates FDA Received: 11/27/2018; 03/07/2019; 03/26/2019; 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1