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

Catalog Number B4219-2

Device Problem High Test Results (2457)

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

Event Date 03/17/2014

Event Type  malfunction  

Event Description

Discrepant elevated activated partial thromboplastin time (aptt) results were obtained on qc and patient samples.Patient results were reported to the physician during an interval of incorrect aptt protocol settings.The qc samples were repeated with the correct protocol settings and lower, within range results were obtained.It is unknown if patient treatment was altered or prescribed due to discrepant aptt results reported.There is no report of adverse outcome to the patients as a result of the discrepant aptt results.

Manufacturer Narrative

The cause of the discrepant elevated activated partial thromoboplastin time results is user error.The account entered the incorrect u.S.Settings calibration curve input for the activated partial thromboplastin time (aptt) with actin fsl using lot 547378.These values are manually input by the operator.The incorrect curve has been in use since mid-february.The issue was resolved by directing the account to use a u.S.Settings calibration curve with the appropriate input for the aptt with actin fsl.The instrument is performing within specifications.No further evaluation of the device is required.

• 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, 3504 1; GM 35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; 76 emil von behring strasse; marburg, 3504 1; GM 35041
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 3777273
• MDR Text Key: 21719176
• Report Number: 9610806-2014-00018
• 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 Facility
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 04/01/2015
• Device Catalogue Number: B4219-2
• Device Lot Number: 547378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/08/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1