MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BERICHROM(R) HEPARIN

Catalog Number OWLD115

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2013

Event Type  malfunction  

Event Description

A discordant low heparin result was obtained on a patient sample.The result was not reported to the physician.The sample was repeated with freshly prepared reagents and a higher result was obtained in better accord with patient history.The repeat result was reported.Patient treatment or diagnosis was not altered on the basis of the discordant low patient heparin result.There was no report of adverse health consequences as a result of the discordant low patient heparin result.

Manufacturer Narrative

The cause of the discordant low heparin result is user error.This event and other similar occurences at the same account with the same reagent system were instances of improper reagent handling by the same technologist.The supervisor at the account does not suspect a product issue.The supervisor at the account committed to retraining of the technologist on proper reagent preparation and handling.In each occurence the issue was resolved with proper preparation of fresh reagents.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: BERICHROM(R) HEPARIN
• Type of Device: BERICHROM(R) HEPARIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; 76 emil von behring strasse; marburg, 3504 1; GM 35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; 76 emil von behring strasse; marburg, 3504 1; GM 35041
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 3596338
• MDR Text Key: 4091170
• Report Number: 9610806-2014-00008
• Device Sequence Number: 1
• Product Code: KFF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925200
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Medical Technologist
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 05/27/2016
• Device Catalogue Number: OWLD115
• Device Lot Number: 43091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1