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

Model Number	DADE ACTIN FS ACTIVATED PTT REAGENT
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that two discordant, falsely elevated activated partial thromboplastin time (aptt) results were obtained on two patient samples from the same patient 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, 9610806-2019-00054, and 9610806-2019-00055 were filed for additional results for samples from the same patient.
Event or Problem Description
Two discordant, falsely elevated activated partial thromboplastin time (aptt) results were obtained on two patient samples from the same patient on a sysmex cs-5100 system using dade actin fs activated ptt reagent (lot#: 538551).The discordant results were reported to the physician(s).The following day, a different sample from the same patient 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 results, 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.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2019-00053 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, 9610806-2019-00054_s1, and 9610806-2019-00055_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
• Common Device Name: 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: 8696730
• Report Number: 9610806-2019-00053
• Device Sequence Number: 13925422
• Product Code: GGW
• UDI-Device Identifier: 00842768003844
• UDI-Public: 00842768003844
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K811589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

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: 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
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1