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

Catalog Number B4218-100 SMN 10445710

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

The cause of the discordant elevated aptt result is a use error.An incorrect test protocol was in place in the software for the actin fs aptt reagent since installation in 2015.A siemens healthcare diagnostics technical assistance specialist (tas) incorrectly entered the actin fsl test protocol at the account when the actin fs reagent was installed on the ca-660 instrument on (b)(6) 2015.The incorrect settings were in use for actin fs lots 538492 and 538503.The error was discovered when the account requested the tas to assist them in switching from the actin fs reagent to actin fsl reagent in (b)(6) 2017.The account stated that they have been participating in the siemens healthcare quality assurance program.Quality control values have been recovering in the peer ranges.They also stated that there have been no proficiency survey failures during the period of incorrect settings.The account is a free standing emergency department and stated that their physicians do not use the actin fs reagent aptt for heparin monitoring.The account stated that their physicians have not questioned results during the period.The tas entered correct assay settings for actin fsl to complete the switch to the alternate aptt reagent in (b)(6) 2017.The account is now using the actin fsl reagent with the correct protocol for aptt with actin fsl on the ca-660 system.No further issues have been reported.The issue is resolved.The device is performing within specifications.No further evaluation of the device is required.

Event Description

Discordant activated ptt (aptt) results were obtained on qc and patient samples run with the actin fs reagent on the ca-660 instrument.Results were reported to the physicians over a period of time since assay installation in which incorrect reagent settings had been in use.In studies conducted after the use of incorrect settings was discovered, data showed higher or lower results may have been obtained.No corrected results were issued.There is no indication that patient treatment was altered or prescribed on the basis of the discordant aptt results.There is no indication of adverse health consequences to the patient on the basis of the discordant aptt results.

• Brand Name: DADE ACTIN FS ACTIVATED PTT REAGENT
• Type of Device: DADE ACTIN FS ACTIVATED PTT REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, D-350 41; GM D-35041
• Manufacturer Contact: james morgera ; glasgow business community; 500 gbc drive po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 6346859
• MDR Text Key: 68039536
• Report Number: 9610806-2017-00025
• Device Sequence Number: 1
• Product Code: GGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K811589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2017
• Device Catalogue Number: B4218-100 SMN 10445710
• Device Lot Number: 538503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2015
• 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