MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE PATHROMTIN SL

Catalog Number OQGS

Device Problem High Test Results (2457)

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

Event Date 07/21/2014

Event Type  malfunction  

Event Description

Falsely elevated activated partial thromboplastin time (aptt) results were obtained on multiple patient's samples run with the dade pathromtin sl reagent.The patient results were reported to the physician who questioned the results.The patient samples were repeated when qc was found to be out of range high.Patient results were repeated and lower results were obtained.It is unknown if patient treatment was altered on the basis of the falsely elevated aptt results.There is no report of adverse outcome to patients as a result of the falsely elevated aptt results.

Manufacturer Narrative

The cause of the discrepant falsely elevated aptt results is unknown.Qc at 5:41 was out of range, indicating a potential issue with the reagent vial that had been on board of the instrument for greater than 40hr.Based on internal testing and the complaint investigation, siemens has no evidence for a systematic malfunction of the affected lot.The issue seems correlated with an unknown cause of reduced reagent stability of a single reagent vial while being on board.The issue seems to be a single case at the customer site.Vials tested internally for reagent stability did not shown any deviation from the specifications, and we have no further complaint on the same issue of the affected lot.No further evaluation of the device is required.

• Brand Name: DADE PATHROMTIN SL
• Type of Device: DADE PATHROMTIN SL
• 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; emil von behring strasse 76; marburg, D-35 041; GM D-35041
• Manufacturer Contact: aydee crawford ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026316312
• MDR Report Key: 4019407
• MDR Text Key: 4847191
• Report Number: 9610806-2014-00020
• Device Sequence Number: 1
• Product Code: GFO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K955450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 04/14/2015
• Device Catalogue Number: OQGS
• Device Lot Number: 536664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2014
• Initial Date FDA Received: 08/19/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/06/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1