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

Model Number DADE ACTIN FS ACTIVATED PTT REAGENT

Device Problem High Test Results (2457)

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

Event Date 04/24/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) and reported that a discordant, falsely elevated activated partial thromboplastin time (aptt) result was obtained on a patient sample on a sysmex cs-5100 system using dade actin fs activated ptt reagent.As stated in the limitations of the procedure section of the instructions for use for dade actin fs activated ptt reagent, "actin fs may provide variable aptt results in samples containing the lupus-like anticoagulant." this could have contributed to the discordant results.Report source indicates that the instrument manufacturer, sysmex europe (b)(4), reported this incident to siemens.They provided the complaint from one of their customers.Siemens is investigating the issue.Mdrs 9610806-2019-00052, 9610806-2019-00053, and 9610806-2019-00054 were filed for additional results for samples from the same patient.

Event Description

A discordant, falsely elevated activated partial thromboplastin time (aptt) result was obtained on a patient sample on a sysmex cs-5100 system using dade actin fs activated ptt reagent (lot#: 538551).The discordant result was reported to the physician(s), and the result was questioned by the physician(s).The same sample was sent to a different lab and was run for aptt on a non-siemens instrument with unknown reagent, resulting in a lower aptt result.The repeat result was reported, as the correct result, to the physician(s).Due to the discordant falsely elevated aptt result, vitamin k reversal therapy was started on the patient; however, there were no adverse health consequences to the patient as a result of the vitamin k reversal therapy.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2019-00055 on 13-jun-2019.Additional information (19-jun-2019): siemens further investigated the issue.According to the information provided, lupus anticoagulant (la) is present in the patient sample.La is known to interfere with the dade actin fs activated ptt (aptt) reagent which is described in the dade actin instruction for use (ifu): "actin fs may provide variable aptt results in samples containing the lupus-like anticoagulant.Unexpected abnormal aptt results should always be followed by additional coagulation studies to determine the source of abnormal results".The discrepant results are due to the la interferences as described in the dade actin ifu.Result code and conclusion code in section h6 were updated based on the additional information.Supplemental mdrs 9610806-2019-00052_s1, 9610806-2019-00053_s1, and 9610806-2019-00054_s1 were filed for additional results for samples from the same patient.The reagent is performing according to specifications.No further evaluation of this device is required.

• Brand Name: DADE ACTIN FS ACTIVATED PTT REAGENT
• Type of Device: DADE ACTIN FS ACTIVATED PTT REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg d-35041, ; GM
• MDR Report Key: 8696828
• MDR Text Key: 149808282
• Report Number: 9610806-2019-00055
• Device Sequence Number: 1
• Product Code: GGW
• UDI-Device Identifier: 00842768003844
• UDI-Public: 00842768003844
• Combination Product (y/n): N
• PMA/PMN Number: K811589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/26/2020
• Device Model Number: DADE ACTIN FS ACTIVATED PTT REAGENT
• Device Catalogue Number: 10445710
• Device Lot Number: 538551
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1