MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE INNOVIN

Catalog Number B4212-50

Device Problems Use of Device Problem (1670); Low Test Results (2458)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/01/2015

Event Type  malfunction  

Manufacturer Narrative

The cause of the biased low pt inr results is user error.The account did not properly enter the correct lot specific isi and mnpt values for the dade innovin lot in use.The siemens healthcare diagnostics customer care center- technical solutions representative assisted the account in entering the correct lot specific isi and mnpt values for the innovin lot in use.The instrument is performing within specifications.No further evaluation of the device is required.

Event Description

The customer reported low biased prothrombin time inr (pt-inr) results on a ca-620 instrument with the dade innovin reagent.The account discovered that there had been an error in the isi (international sensitivity index) and mnpt (mean normal pt) settings for the lot that had been in use.Patient pt-inr results were reported to the physicians during the period of the incorrect settings.There is no indication that physicians questioned patient results reported with the incorrect settings in place.Calculations show that higher results would have been reported with the correct isi and mnpt settings.It is unknown if patient treatment was altered or prescribed on the basis of the low biased pt-inr results.There is no report of adverse outcome to patients as a result of the low biased pt-inr results.

• Brand Name: DADE INNOVIN
• Type of Device: DADE INNOVIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; 76 emil von behring strasse; marburg, 35041 ; GM 35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; 76 emil von behring strasse; marburg, 35041 ; GM 35041
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 5909833
• MDR Text Key: 53291654
• Report Number: 9610806-2016-00024
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974343
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 10/23/2016
• Device Catalogue Number: B4212-50
• Device Lot Number: 539280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/08/2014
• 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