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

Catalog Number B4218

Device Problem Low Test Results (2458)

Patient Problem No Information (3190)

Event Date 04/24/2015

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics has confirmed complaints about downward drifting recovery of control plasma p lots 509973a and 509973c with lots 538484 and 538485a of dade® actin®fs activated ptt reagent on the bcs/bcs xp system.The impact on patient sample recovery with the dade actin fs activated ptt reagent lots was investigated.The investigation showed no effect on patient sample recovery.No lookback for previously reported patient test results was recommended.No u.S.Customers received the affected product.A customer letter was distributed to outside us customers.The outside us customer letter br-04815 dated june 2015 was issued to the potentially impacted customers.The communication was sent to inform those customers using the combination of actin fs and control plasma p on the bcs/bcs xp system about the issue and to recommend usage of an alternate control plasma p lot of dade ci-trol 2/citrol 3 as pathological control instead of control plasma p.

Event Description

A customer complained of downward drift of control plasma p (cpp) control recoveries with actin fs activated ptt reagent on the bcs system.Patient samples were run during the period of control recovery drift.The complainant gave no indication of patient sample results being questioned by physicians during the period of control recovery drift.There is no indication of patient treatment being altered or prescribed during the period of control recovery drift.There was no report of adverse health consequences during the period of control recovery drift.

Manufacturer Narrative

Siemens healthcare diagnostics inc.Filed the initial mdr (9610806-2016-00007) on february 11, 2016.February 12, 2016 additional information: no us customers received the affected product.A customer letter was distributed to outside us customers.The outside us customer letter br-02315 dated march 2015 was issued to the potentially impacted customers.The communication was sent to inform those customers using the combination of actin fs and control plasma p on the bcs/bcs xp system about the issue and to recommend usage of an alternate control plasma p lot of dade ci-trol 2/ci-trol 3 as pathological control instead of control plasma p.

• 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; 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: 5431394
• MDR Text Key: 38085320
• Report Number: 9610806-2016-00007
• Device Sequence Number: 1
• Product Code: GGW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K811589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 04/23/2016
• Device Catalogue Number: B4218
• Device Lot Number: 538484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2015
• 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: N
• Patient Sequence Number: 1