MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE ACTIN FSL ACTIVATED PTT REAGENT

Model Number DADE ACTIN FSL ACTIVATED PTT REAGENT

Device Problem High Test Results (2457)

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

Event Date 10/08/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) and reported that quality control (qcs) recovered out of range(s) for d-dimer and activated partial thromboplastin time (aptt) on the sysmex cs-2500 system.While no patient samples were run for d-dimer when qcs recovered out of ranges, discordant, falsely elevated aptt results were obtained on patient samples.There were no reports of system errors generated when the discordant aptt results were obtained.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse reported that the issue was resolved before he arrived and when the cse ran qcs, the qcs recovered within acceptable ranges for d-dimer and aptt.The cse inspected the mechanical positions on the system and determined that adjustments were not required.Then, the cse observed an error in system's error log ("error in hydraulic line for rinse cup ejection in sample probe") and determined that the sample cup rinse was not being drained fast enough, causing an overflow; the cse bleached valve 2 and the rinse drain operated acceptably.The cse reported that qcs were within acceptable ranges prior to and after the cse bleached valve 2.Siemens further investigated the issue and determined that the sample cup rinse overflow may have contributed to the discordant, falsely elevated aptt results.Siemens reached out to the customer with questions regarding the affected patient samples and impacted reagent lots, and how the issue was resolved prior to the cse's visit; however, the customer has not responded thus far.The lot number and unique identifier number (udi) for the dade actin fsl activated ptt reagent were not available at the time of filing this mdr.The reagent is performing according to specifications.No further evaluation of this device is required.

Event Description

Discordant, falsely elevated activated partial thromboplastin time (aptt) results were intermittently obtained on patient samples on a sysmex cs-2500 system, using the dade actin fsl activated ptt reagent, on (b)(6) 2018.The discordant results were reported to the physician(s).When the samples were repeated on an alternate sysmex ca-1500 system, lower results were obtained on the samples.The repeat results were reported, as the correct results, to the physician(s).The customer reported that they transferred all patient samples to the sysmex ca-1500 system for testing.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated aptt results.

• Brand Name: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Type of Device: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• Manufacturer Contact: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9145243504
• MDR Report Key: 8032166
• MDR Text Key: 125915876
• Report Number: 9610806-2018-00113
• Device Sequence Number: 1
• Product Code: GGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K863594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Device Catalogue Number: 10445714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2018
• 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