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 High Test Results (2457)

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

Event Date 09/09/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens healthcare diagnostics inc.(siemens) technical solutions center (tsc) specialist directed the customer to run a precision test to determine the cause of the potentially discordant activated partial thromboplastin time (aptt) results on the sysmex ca-620 system and the customer did not follow the recommended instructions.The tsc specialist advised the customer to not report patient results until the issue is resolved.The customer indicated the issue is resolved and they refused service.The customer indicated that they stopped experiencing issues once they started using conical cups on internal quality controls.The cause of the potentially discordant aptt results is unknown.The system is performing according to specifications.No further evaluation of this system is required.Mdr 9610806-2017-00107 and mdr 9610806-2017-00108 were filed for the same event.

Event Description

A potentially discordant activated partial thromboplastin time (aptt) result was obtained on a patient sample on the sysmex ca-620 system.This result was not reported to the physician.The same patient sample was rerun on the same system, resulting lower.The repeated result was not reported to the physician and the correct result for this patient is unknown.Prior to running the patient sample, the customer experienced issues with the internal quality controls.The customer indicated that internal quality controls recovered within range once she ran internal quality controls in a conical cup, as oppose to running them in sample tubes.The customer indicated that she ran the patient samples after the internal quality control recovered within expected ranges.There are no known reports of patient intervention or adverse health consequences due to the potentially discordant aptt results obtained on this patient sample.

• 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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• Manufacturer Contact: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9145243504
• MDR Report Key: 6916861
• MDR Text Key: 89485948
• Report Number: 9610806-2017-00109
• Device Sequence Number: 1
• Product Code: GGW
• UDI-Device Identifier: 00842768003875
• UDI-Public: 00842768003875
• 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 faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2018
• Device Model Number: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Device Catalogue Number: 10445713
• Device Lot Number: 547496A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 17 YR