MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION® FERRITIN FLEX® REAGENT CARTRIDGE; DIMENSION® FERR FERRITIN FLEX® REAGENT CARTRIDGE

Catalog Number RF440 SMN10444946

Device Problem Low Test Results (2458)

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

Event Date 06/26/2016

Event Type  malfunction  

Manufacturer Narrative

Analysis of instrument data by siemens healthcare diagnostics indicates that the cause for the falsely depressed ferritin (ferr) result was a hook effect.The customer was inquiring about a low unflagged result.The dimension ferr instructions for use (ifu) addresses the potential for hook effect.It states: "one-step sandwich immunometric assays are susceptible to a high-dose "hook effect," where an excess of antigen prevents simultaneous binding of the capture and detection antibodies to a single analyte molecule.Such samples must be diluted and reassayed prior to reporting the results.The ferr method shows no hook effect up to at least 100,000 ng/ml ferritin." in this instance, the patient sample true results exceeded 100,000 and a discrepant result was unflagged for high absorbance.The reagent is performing within ifu claims.No further evaluation of the device is required.

Event Description

A falsely depressed ferritin (ferr) result was obtained on a patient sample.The result was reported to the physician.The sample was repeated and a higher result was obtained in concordance with prior patient ferr results and physician expectation.Patient treatment was altered on the basis of the falsely depressed ferr result.A planned medical procedure was postponed.The nature of the procedure was not disclosed.There was no report of adverse health consequences as a result of the falsely elevated ferr result or the procedure postponement.

• Brand Name: DIMENSION® FERRITIN FLEX® REAGENT CARTRIDGE
• Type of Device: DIMENSION® FERR FERRITIN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 5801841
• MDR Text Key: 49757515
• Report Number: 2517506-2016-00281
• Device Sequence Number: 1
• Product Code: JMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963498
• 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: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 04/14/2017
• Device Catalogue Number: RF440 SMN10444946
• Device Lot Number: DA7104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2016
• Initial Date FDA Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2016
• 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