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

Catalog Number B4219-2

Device Problem Low Test Results (2458)

Patient Problem No Information (3190)

Event Date 06/29/2014

Event Type  malfunction  

Event Description

Depressed activated partial thromboplastin time (aptt) results well below laboratory reference ranges were obtained on patient samples.Patient results were reported to the physician who questioned the results as discordant low.The account notes that there was a delay in patient surgery due to the repeat testing of the depressed aptt results for one patient.It is unknown if patient treatment was otherwise altered or prescribed due to questioned, depressed aptt results.There is no report of adverse outcome to the patients as a result of the questioned, depressed aptt results.

Manufacturer Narrative

The cause of the discrepant depressed activated partial thromboplastin time results is unknown.Siemens healthcare diagnostics has neither an indication for a malfunction of the analyzer nor for a performance issue of the reagent being used.The instrument is performing within specifications.

• 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: aydee crawford ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026316312
• MDR Report Key: 3965825
• MDR Text Key: 4609104
• Report Number: 9610806-2014-00021
• 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 Facility
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 06/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 10/09/2015
• Device Catalogue Number: B4219-2
• Device Lot Number: 547389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2014
• 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