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

Catalog Number B4219 SMN 10445714

Device Problem High Test Results (2457)

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

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

The cause of the falsely elevated aptt results is unknown.The true recovery of the patient samples is not clear with the information provided.Siemens is unable to rule out improper collection or handling of the samples.Per siemens healthcare support center analysis, the original sample recovery of 62 seconds produced a recovery of 33.8 seconds when repeat analysis was performed on the same sample after 5 hours.The sample, when aged 5 hours was no longer within acceptable stability for the aptt assay when assessing for unfractionated heparin.Samples collected for coagulation testing for patients on unfractionated heparin therapy must be centrifuged within 1 hour of collection and tested within 4 hours.Delay in centrifugation will lead to platelet neutralization of the heparin in the plasma.If the sample was left in the original tube between the original run and repeat analysis, the platelets may re-suspend in the plasma and also lead to platelet neutralization of the heparin in the plasma.Neutralization of heparin in the plasma would lead to falsely decreased values.The account stated that there may have been a bubble aspirated with the evening sample.The instrument and reagent are performing within specifications per qc results.There were no report of discordant or questionable results on any other patients.No further evaluation of the devices is required.

Event Description

A falsely elevated activated ptt (aptt) result was obtained on a patient sample run with the actin fsl reagent on the bcs-xp instrument.The result was reported to the physician.There is no indication if the physician questioned the result or why a repeat test on the same sample was conducted.The sample was repeated 5 hours later and a lower result was obtained which was more consistent with prior results on the same patient.The lower result was regarded as concordant by the laboratory.A corrected report was issued.A subsequent sample was drawn that evening and an elevated result was again obtained.A new sample drawn at noon of that day gave a result in the therapeutic range.The lower result was again regarded as concordant by the laboratory.There is no indication that patient treatment was altered or prescribed on the basis of the initial elevated aptt result.Patient treatment was altered on the basis of the evening elevated aptt result.The heparin dosage was reduced.There is no indication of adverse health consequences to the patient on the basis of the falsely elevated aptt result or due to the heparin dosage reduction.

• Brand Name: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Type of Device: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; 76 emil von behring strasse; marburg, 35041 ; GM 35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; 76 emil von behring strasse; marburg, 35041 ; GM 35041
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 5761191
• MDR Text Key: 48514728
• Report Number: 9610806-2016-00019
• Device Sequence Number: 1
• Product Code: GGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K863594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 08/03/2016
• Device Catalogue Number: B4219 SMN 10445714
• Device Lot Number: 547432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/26/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 90 YR