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 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

The cause of the shifted high aptt results is unknown.Siemens evaluated the data.The shift high was observed in some patients, not all patients.Actual patient values and repeat testing was requested, however, was not provided by the customer to determine if values were truly erroneous.They observed a shift upward in some patient recovery where they expect normal values since (b)(6) 2016.They did not observe a shift upward in control recovery.The issue resolved with a new shipment of the lot of reagent that had been in use at the account since (b)(6) 2015.The account believes this was resolved with a new shipment of reagent.No further evaluation of the devices is required.

Event Description

The account noted a shift upward in activated ptt (aptt) patient results with the actin fsl reagent lot 547448 on the ca-7000 instrument over a period since (b)(6) 2016.No shift in qc results was noted during the same period.During the period patient results were reported to physicians.There is no indication that patient treatment was altered or prescribed on the basis of falsely elevated aptt results.There is no indication of adverse health consequences to patients on the basis of the falsely elevated aptt results.

• 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: 5761189
• MDR Text Key: 48514872
• Report Number: 9610806-2016-00021
• 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: 11/03/2016
• Device Catalogue Number: B4219 SMN 10445714
• Device Lot Number: 547448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/26/2014
• 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 Outcome(s): Congenital Anomaly