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

Catalog Number 10445713

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/12/2018

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics inc.Has investigated the cause of the discordant activated partial thromboplastin time (aptt) patient results generated on the sysmex ca-620 system and determined that the differences observed for the aptt in seconds between the 2 labs can be further explained by a difference in the systems and lot numbers of reagents being used.As stated in the reagent instructions for use, results should be related to the normal range in each laboratory.Reference intervals vary from laboratory to laboratory depending on the population served and the technique, method, equipment and reagent lot used.The aptt results are within the respective normal ranges for each lab.Siemens determined that there is no evidence of a reagent, instrument or software malfunction.The customer service engineer (cse) adjusted the detector well temperature and ran quality control (qc) without issue.The differences observed between the aptt results between the labs is potentially due to the difference in systems and reagent lots used.No further evaluation of this device is required.The systems and reagents are performing according to specifications.Mdr 9610806-2018-00055 was filed for the pt patient results using dade innovin lot 539388.

Event Description

Multiple discordant prothrombin time (pt) patient sample results were generated on a sysmex ca-620 system (serial number (b)(4)) and reported to physicians using dade innovin lot 539388 when quality control (qc) for pt was out of range.Some patient samples were run for activated partial thromboplastin time (aptt) using dade actin fsl activated ptt reagent lot 556912.On the following day ((b)(6) 2018), all patient samples were retested at an alternate laboratory on a sysmex cs-2500 system, using dade innovin lot 549704 and dade actin fsl activated ptt reagent lot 556904.No corrected reports were issued to physicians.There are no reports of patient intervention or adverse health consequences due to the differences in aptt results between the two laboratories.

• 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 strasse 76; marburg, 35041 ; GM 35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, 35041 ; GM 35041
• Manufacturer Contact: loriann russo ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242287
• MDR Report Key: 7666615
• MDR Text Key: 113514824
• Report Number: 9610806-2018-00056
• 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: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2019
• Device Catalogue Number: 10445713
• Device Lot Number: 556912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2018
• 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