MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DATE(R) ACTIN(R) ACTIVATED CEPHALOPLASTIN REAGENT; DATE(R) ACTIN(R) ACTIVATED CEPHALOPLASTIN REAGENT,

Catalog Number B4218-1

Device Problem High Test Results (2457)

Patient Problem No Information (3190)

Event Date 04/20/2015

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics has confirmed internally that for a group of affected action lots including lot 557136, the recovery of controls can be found outside the assigned ranges.Furthermore, a drift in the normal range towards higher results has been observed.This indicates a change of the product performance over the shelf life.Siemens has confirmed a drift greater than 3 seconds in the normal aptt range and / or greater than 15 % in the pathological range over the shelf-life.It is possible that patients with values close to the medical decision points could exhibit a deviation of up to 4 seconds for the normal range and up to 33% for the pathological range.The described drift towards higher aptt values will be recognized in most cases by control recovery out of the assigned range.No u.S.Customers received the affected product.A customer letter (b)(4) was distributed to outside the us customers only.It advised customers who had ordered the affected lots to discontinue the use of the lots.Siemens offered a no charge replacement with a non-impacted lot.

Event Description

The customer experienced biased high qc recoveries for activated partial prothrombin time (aptt) without of range recovery for actin lot 557136 with ci-trol 1 lot 528157b and ci-trol 2 lot 548244a.They also complained of vial to vial variability for this actin lot.It is unknown if patient results were reported to physicians while the lot was in use.It is unknown if patient treatment or diagnosis was altered on the basis of the biased high aptt qc results.There was no report of adverse health consequences as a result of the biased high aptt qc results.

• Brand Name: DATE(R) ACTIN(R) ACTIVATED CEPHALOPLASTIN REAGENT
• Type of Device: DATE(R) ACTIN(R) ACTIVATED CEPHALOPLASTIN 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: 5430000
• MDR Text Key: 37986215
• Report Number: 9610806-2016-00011
• Device Sequence Number: 1
• Product Code: GFO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K760318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/28/2015

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: 12/12/2015
• Device Catalogue Number: B4218-1
• Device Lot Number: 557136
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/21/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 9610806-03-24-2015-002-C
• Patient Sequence Number: 1