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 03/16/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).A siemens technical application specialist (tas) was at the customer's site for training purposes.Siemens advised the customer to repeat these samples using an alternate method as these results were not reportable.As per the sysmex cs-2500 system instructions for use (ifu), all results were flagged with errors that advise the operator to review the coagulation curve and if required, repeat the test.The customer incorrectly reported the result of approximately 30 seconds.Siemens further investigated the data provided by the customer and determined that the system flagged the results as intended.Siemens determined that the heparin and propofol medications, which the patient was taking at the time of the testing, potentially influenced the activated partial thromboplastin time (aptt) result.Siemens determined that propofol also potentially contributed to the turbid appearance of the affected samples.The customer performed a use error by reporting the flagged result.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

Flagged, non-numerical activated partial thromboplastin time (aptt) results were obtained on four samples from the same patient using the dade actin fsl activated ptt reagent on two sysmex cs-2500 systems.Three samples were rerun on the same instruments, resulting in other flagged, non-numerical aptt results.The customer did not provide the data for the third sample and stated that an aptt result of approximately 30 seconds was reported to the physician(s).A sample from this patient was sent to alternate laboratory and run using a sysmex ca-7000 system, resulting in an aptt result of "no coagulation".A corrected report was not provided to the physician(s).It was alleged that the patient's heparin administration was delayed due to the discordant result reported on the patient sample.There are no known reports of adverse health consequences due to the discordant aptt result reported on the patient sample.

Event Description

Based on the results obtained on samples from this patient, the customer reported a result of 28 seconds to the physician(s) with a disclaimer regarding the sample integrity.The customer also suggested sending a sample to another lab for confirmation purposes.There were no reports of impact to the patient due to the delay of heparin administration and the patient was discharged from the facility on (b)(6) 2018.The customer also reported that the patient was in critical condition prior to reporting the discordant result due to cancer and other health issues.

Manufacturer Narrative

Additional information (12-apr-2018): there were no reports of impact to the patient due to the delay of heparin administration and the patient was discharged from the facility on (b)(6) 2018.The customer reported that the patient was in critical condition prior to reporting the discordant result due to cancer and other health issues.On 2018, the patient was tested for activated partial thromboplastin time (aptt) and prothrombin time (pt), resulting in aptt results of >139 seconds and "no coagulation" and a pt result of 14.3 seconds.Subsequent aptt results were obtained for the patient on (b)(6) 2018 and results of 23 seconds and 32 seconds were obtained for this patient.The customer reported that there was no issue with phlebotomy, integrity of the samples or centrifugation.Siemens further investigated the event and observed abnormal clot formation in the reaction kinetics.Siemens determined that the results obtained on samples from this patient were not reportable and that the sample integrity was acceptable, but appeared hazy.Based on the sysmex cs-2500 system evaluation and check algorithm bulletin, "early reaction" errors are triggered when abnormally short aptt results are caused by an early reaction and masked results "****.*" will be produced; the user should review the curve prior to reporting the result or rerun the sample.If the error remains after repeat analysis, these results are potentially caused the quality of the sample due to patient's unusual clinical situation.Siemens determined that co-morbidity and administration of numerous medications may lead to challenges in obtaining coagulation results.Based on the medication list provided by the customer and review of the measurement curves, siemens concluded that a prolonged coagulation, which may extend beyond the report limit of 139 seconds, was expected for these samples.The technical application specialist (tas), that was on the customer's site for training purposes, trained the technologists in the facility on how to review measurement curves on the sysmex cs system.Corrected information (20-apr-2018): the customer initially stated that they reported a result of approximately 30 seconds to the physician(s).On (b)(6) 2018, the customer clarified that they reported "28 seconds" to the physician(s) with a disclaimer regarding the sample integrity.The customer also suggested sending a sample to another lab for confirmation purposes.

• 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: 7430140
• MDR Text Key: 105914818
• Report Number: 9610806-2018-00042
• 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: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• 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: 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR