MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH PATHROMTIN SL

Model Number PATHROMTIN SL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

The operator contacted a siemens healthcare diagnostics inc.(siemens) technical application specialist (tas) to determine which result they should report for activated partial thromboplastin time (aptt) and whether the pathromtin sl reagent can be used to monitor low-molecular weight (lmw) heparin therapy.The operator indicated that they routinely use the actin fsl reagent to test for aptt and they use the pathromtin sl reagent specifically to test heparinized patients and for this patient they obtained different results when they tested the patient's blood in parallel using the pathromtin sl and actin fsl reagents.The operator did not provide the lot numbers of the pathromtin sl and actin fsl reagents.Siemens has determined that actin fsl and pathromtin sl reagents are not recommended for monitoring of aptt when the patient is on low-molecular weight (lmw) heparin therapy.The instruction for use (ifu) for the actin fsl and pathromtin sl reagents do not have performance claims for monitoring lmw heparin therapy.Siemens offers four different aptt reagents which provide options in sensitivity to heparin, lupus anticoagulants, and factor deficiencies that allows customers to select a reagent type that is most appropriate for monitoring their specific patient population.The variation in sensitivity can lead to differences in the aptt results on patient samples.The instrument and reagents are performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2017-00073 and mdr 9610806-2017-00074 were filed for the same event.

Event Description

A patient was administered low-molecular weight (lmw) heparin therapy after receiving surgery and tested for activated partial thromboplastin time (aptt).In parallel, the operator analyzed the patient blood for aptt using the actin fsl and pathromtin sl reagents and obtained different aptt results.The operator obtained an aptt result of 169.5 seconds using the pathromtin sl reagent and obtained an aptt result of 28 seconds using the actin fsl reagent.An aptt result of 169.5 seconds was reported to the physician.The operator stated that aptt result obtained using the pathromtin sl reagent was considered discordant since aptt results generally will not increase due to lmw heparin therapy.The operator indicated they explained the situation to the physician such that these aptt results did not affect the patient.The operator indicated that the physician treated the patient according to standard medical protocols and other test results.There are no known reports of patient intervention or adverse health consequences due to the different aptt results obtained between the pathromtin sl and actin fsl reagents.

Manufacturer Narrative

Siemens healthcare diagnostics inc.(siemens) filed the initial mdr 9610806-2017-00072 on july 20, 2017.July 21, 2017 additional information: upon further investigation, siemens determined that there was no potential for death or serious injury for this incident.There is negligible potential for injury if this type of incident were to recur.Supplemental mdrs 9610806-2017-00073_s1 and 9610806-2017-00074_s1 were filed for the same event.

• Brand Name: PATHROMTIN SL
• Type of Device: PATHROMTIN SL
• 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; D-350 41; GM D-35041
• Manufacturer Contact: elizabeth bernasconi ; 511 benedict ave; tarrytown, NY 10591 ; 9145242495
• MDR Report Key: 6730153
• MDR Text Key: 80763907
• Report Number: 9610806-2017-00072
• Device Sequence Number: 1
• Product Code: GFO
• UDI-Device Identifier: 00842768007521
• UDI-Public: 00842768007521
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K955450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/31/2017

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
• Device Operator: Health Professional
• Device Model Number: PATHROMTIN SL
• Device Catalogue Number: 10446066
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2017
• Initial Date FDA Received: 07/20/2017
• Supplement Dates Manufacturer Received: 07/21/2017
• Supplement Dates FDA Received: 07/31/2017
• 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
• Patient Age: 80 YR