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 Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/14/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that they reviewed the integrity of the sample and determined that the sample was slightly hemolyzed.A siemens headquarters support center (hsc) specialist analyzed the event and determined that no other discordant results were obtained using the dade actin fsl activated ptt reagent on (b)(6) 2018.However, a hsc specialist determined that the initial activated partial thromboplastin time (aptt) result was appropriately flagged and a sample collection, sample handling or other pre-analytical variables potentially contributed to the discordant, falsely elevated aptt result.As per dade actin fsl activated ptt reagent's instruction for use (ifu), unfractionated (uf) heparin therapy can lead to an increase in aptt results.A hsc specialist determined that uf heparin influence is not typically associated with discordant results of this magnitude upon immediate re-analysis.Siemens communicated these potential causes to the customer and provided the customer with the sysmex ca series measurement evaluation and check method scientific bulletin.The patient was on an extracorporal life support system (heart/lung pump) and uf heparin therapy.A hsc specialist determined that there was no indication of a malfunction in performance with dade actin fsl activated ptt reagent.Difference in results for prothrombin time (pt), pt international normalized ratio (inr), and fibrinogen (fbg) were also observed upon repeat of the patient sample.Siemens determined the differences between those results were not significant since the pt results were in the supratherapeutic area and the fbg results were all below the reference range.The system and reagent are performing according to specifications.No further evaluation of this system and reagent is required.

Event Description

The customer reported that an elevated activated partial thromboplastin time (aptt) result, flagged with "analysis time over" and "early reaction error", was obtained on a patient sample using the dade actin fsl activated ptt reagent on the sysmex ca-1500 system.The customer indicated that this result was not reported to the physician(s).Based on the "sysmex ca series measurement evaluation and check method scientific bulletin" (page 12), the "analysis time over" flag determines whether the reaction end point is correct; this flag is triggered when testing samples with prolonged clotting times.In such cases, the user should check the sample integrity, verify the delivery of sample and reagent, set the "maximum reading time" to a longer time, and repeat analysis.If the repeat result is a numerical value (without an asterisk (*)), the result can be reported.Based on pages 18 and 19 of the same bulletin, the user should not report results with "early reaction error" without reviewing the reaction curve.The user should verify sample and reagent integrity, print analysis data, check analysis printout, and repeat the measurement.Consistent with the instructions in the bulletin, the sample was repeated twice using the same reagent, resulting in lower results both times.The customer indicated that the final aptt result of 94.8 seconds was reported to the physician(s).The customer reported that the patient eventually expired from complications in surgery, not related to laboratory results.There are no known reports of patient intervention or adverse health consequences due to the flagged aptt result.Statements attributed to the physician and customer are derived from information submitted to siemens complaint handling system and haven't been verified.

• 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: 7343357
• MDR Text Key: 102594788
• Report Number: 9610806-2018-00031
• Device Sequence Number: 1
• Product Code: GGW
• UDI-Device Identifier: 00842768003882
• UDI-Public: 00842768003882
• 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: Health Professional
• Type of Report: Initial
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2019
• Device Model Number: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Device Catalogue Number: 10445714
• Device Lot Number: 556916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2018
• 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