MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT 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 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted siemens customer care center (ccc) and reported that an operator misinterpreted the "no coagulation" error as the "flat curve" error and incorrectly reported a flagged activated partial thromboplastin time (aptt) result of <20 seconds.Siemens investigated the issue and determined that quality controls were within expected ranges at the time of the event and correct results were produced by the sysmex cs-2500 systems.Based on the sysmex cs-2500 evaluation and algorithm bulletin, "no coagulation" error is triggered when the system is unable to detect a coagulation reaction or a weak clot was formed.The user should: "check the sample for possible anticoagulant contamination, hemolysis, lipemia, etc; verify delivery of sample and reagent; reanalyze the sample with an extended measurement time (within the range of 100 to 1800 seconds) or set "measurement time (sub)" in the test protocol; if reanalysis with extended time gives "no coagulation" message again, the sample is below the detection limits of the detector.Make a comprehensive judgment, taking sample and reagent, etc.Into consideration.If the result is plausible it may be reported as "greater than" per the established laboratory policy.If additional verification is indicated, use your laboratory policy.If additional verification is indicated, use your laboratory's policy to confirm the data." siemens determined that the customer did not follow the instructions in the sysmex cs-2500 evaluation and algorithm bulletin.The cause of the discordant aptt result reported on a patient sample is a use error.The reagent and systems are performing according to specifications.No further evaluation of these devices is required.

Event Description

Non-numerical activated partial thromboplastin time (aptt) results (flagged with "no coagulation") were obtained on three samples from the same patient using the dade actin fsl activated ptt reagent on two sysmex cs-2500 systems.The lab protocol allows the operator to report results flagged with "no coagulation" as greater than the reporting limit as long as the operator reviews the curve and reference the time at 50% as the reportable result.The final result was reported to the physician(s) as <20 seconds and based on this result, the physician(s) restarted the patient's heparin drip at 2 am on (b)(6) 2018.The lab supervisor was made aware of the situation and notified the physician(s), who stopped the patient's heparin drip at 6 am on (b)(6) 2018.On the same day, the patient's blood was redrawn twice and run using the same reagent.The result obtained on the second redrawn sample was reported to the physician(s).There are no known reports of adverse health consequences due to the flagged aptt result reported on the patient sample.

Event Description

The final result was reported to the physician(s) as <20.5 seconds, not <20 seconds.

Manufacturer Narrative

Additional information (20-apr-2018): the customer provided additional quality control (qc) data for the sysmex cs-2500 system with serial number 22107 and siemens determined that qcs were within expected ranges on both systems on (b)(6) 2018.

• Brand Name: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Type of Device: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 7415170
• MDR Text Key: 105518611
• Report Number: 9610806-2018-00041
• Device Sequence Number: 1
• Product Code: GGW
• UDI-Device Identifier: 00842768003882
• UDI-Public: 00842768003882
• Combination Product (y/n): N
• PMA/PMN Number: K863594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1