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

Model Number PATHROMTIN SL

Device Problem High Test Results (2457)

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

Event Date 09/25/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted siemens customer care center (ccc) to report that discordant, falsely elevated activated partial thromboplastin time (aptt) results were obtained on one patient sample(s) on a sysmex cs-2500 system.Siemens reviewed the instrument backup files and determined that quality controls (qcs) were within the expected specifications.Siemens identified that maintenance was performed regularly on the system and all inspected kinetics were evaluated correctly by the system software.The cause of the discordant, falsely elevated aptt result is patient's possible medical condition.The instrument is performing according to specifications.No further evaluation of the device is required.Mdr 9610806-2018-00108 was filed for the same event which occurred on (b)(6) 2018.Mdr 9610806-2018-00109 was filed for the same event which occurred on (b)(6) 2018.Mdr 9610806-2018-00110 was filed for the same event which occurred on (b)(6) 2018.

Event Description

Discordant, falsely elevated activated partial thromboplastin time (aptt) results were obtained on one patient sample(s) on a sysmex cs-2500 system.The initial discordant result was reported to the physician(s), who questioned the result.Multiple samples from one patient were repeated on the same system, resulting falsely high.The patient was re-drawn and the new sample was run on a non-siemens instrument, resulting lower.The result obtained using the non-siemens methodology was reported, as the correct result to the physician(s).The patient's scheduled arthroscopic surgery was delayed due to the pathological, falsely elevated aptt results and further testing was required.The patient tested negative for factor and lupus anti-coagulants.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated aptt result.

Manufacturer Narrative

Mdr 9610806-2018-00108 has been corrected to mdr 9610806-2018-00112.

• Brand Name: PATHROMTIN SL
• Type of Device: PATHROMTIN SL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH; emil-von-behring-str 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 8009187
• MDR Text Key: 126533945
• Report Number: 9610806-2018-00111
• Device Sequence Number: 1
• Product Code: GFO
• UDI-Device Identifier: 00842768007521
• UDI-Public: 00842768007521
• Combination Product (y/n): N
• PMA/PMN Number: K955450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2018
• Device Model Number: PATHROMTIN SL
• Device Catalogue Number: 10446066
• Device Lot Number: 536696A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR