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

Catalog Number OQGS295 SMN 10446066

Device Problem High Test Results (2457)

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

Event Date 02/20/2017

Event Type  malfunction  

Manufacturer Narrative

The cause of the discordant elevated aptt result is unknown.The issue affected the individual sample.Siemens headquarters support center evaluated the information provided.There were no instrument malfunctions identified.The laboratory quality control values were within laboratory ranges.The issue was resolved with repeat testing of the same samples by an alternate siemens methodology.The postponed surgery was performed after evaluation of all testing results.The "pathromtin" sl intended use summary and explanation states: "the use of the aptt as a screening test for coagulation disorders is indicated particularly prior to surgical interventions as this allows potential hemophiliacs to be diagnosed and given special therapeutic protection.The presence of non-specific inhibitors such as the lupus-like anticoagulant may prolong the aptt, but this effect is variable and generally recognized as being related more to the nature of the aptt reagent employed." the device is operating within specifications.No further evaluation of the device is required.

Event Description

A discordant elevated activated partial thromboplastin time (aptt) result was obtained on a patient sample on multiple sysmex instrument systems with the "pathromtin" sl reagent.The result was reported to the physician who questioned the result.The same sample was repeated on the same systems with an alternate siemens aptt reagent, actin fs, and a lower result was obtained and reported.The test was a preoperative screening and the surgery was temporarily postponed.There is no indication that patient treatment was otherwise altered or prescribed on the basis of the discordant elevated aptt result.There was no report of adverse health consequences as a result of the discordant elevated aptt result.

• Brand Name: PATHROMTIN SL
• Type of Device: PATHROMTIN SL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, D-350 41; GM D-35041
• Manufacturer Contact: james morgera ; glasgow business community; 500 gbc drive po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 6431885
• MDR Text Key: 70787835
• Report Number: 9610806-2017-00043
• Device Sequence Number: 1
• Product Code: GFO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K955450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2018
• Device Catalogue Number: OQGS295 SMN 10446066
• Device Lot Number: 536689
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/20/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 79 YR