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

Catalog Number B4219-2 SMN 10445714

Device Problem High Test Results (2457)

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

Event Date 01/08/2017

Event Type  malfunction  

Manufacturer Narrative

The cause of the discordant elevated aptt result is unknown.The information provided was evaluated.The customer stated that quality control was within laboratory ranges and there have been no issues with other patient samples.Siemens headquarters support center is investigating the incident.

Event Description

A discordant elevated activated ptt (aptt) result was obtained on a patient sample run with the actin fsl reagent on the ca-1500 instrument.The result was reported to the physician who questioned the result.The same sample was re-run on the same instrument and a lower results was obtained.A lower result was also obtained on a redraw sample and a corrected report was issued.There is no indication that patient treatment was altered or prescribed on the basis of the discordant elevated aptt result.There is no indication of adverse health consequences to the patient on the basis of the discordant elevated aptt result.

• Brand Name: DADE ACTIN FSL
• Type of Device: DADE ACTIN FSL ACTIVATED PTT REAGENT
• 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: 6321595
• MDR Text Key: 67342304
• Report Number: 9610806-2017-00021
• Device Sequence Number: 1
• Product Code: GGW
• 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: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2018
• Device Catalogue Number: B4219-2 SMN 10445714
• Device Lot Number: 547492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/29/2016
• 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