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

Model Number DADE ACTIN FSL ACTIVATED PTT REAGENT

Device Problem Low Test Results (2458)

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

Event Date 01/18/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center and reported that a discordant, falsely depressed activated partial thromboplastin time (aptt) result was obtained on a sysmex ca-1500 system using the dade actin fsl activated ptt reagent.Siemens is investigating the issue.

Event Description

A discordant, falsely depressed activated partial thromboplastin time (aptt) sample result was obtained on one patient using a sysmex ca-1500 system and the dade actin fsl activated ptt reagent.The sample was auto repeated and the result was similar.The repeat result was reported to the physician(s).Approximately three hours later, the sample was mixed, checked for clots, centrifuged again and retested resulting lower.This result was not reported to the physician(s).A second sample was drawn from the patient and the result agreed with the initial reported result.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed aptt results.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2020-00007 on 13-feb-2020.Additional information (17-feb-2020): quality controls (qc) recovered in range at the time of the event.There were no instrument flags associated with the affected patient results, and no other patient samples were impacted.Pre-analytical variables (such as a delay in mixing the samples after collection or insufficient mixing) or patient specific issues (such as effects of medications and other interferences listed in the reagent instructions for use (ifu)) could not be excluded.The reagent is performing according to specifications.No further evaluation of this device is required.

• 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; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 9707654
• MDR Text Key: 191036451
• Report Number: 9610806-2020-00007
• Device Sequence Number: 1
• Product Code: GGW
• UDI-Device Identifier: 00842768003875
• UDI-Public: 00842768003875
• Combination Product (y/n): N
• PMA/PMN Number: K863594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2020
• Device Model Number: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Device Catalogue Number: 10445713
• Device Lot Number: 556959
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR