MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION(R) CLINICAL CHEMISTRY SYSTEM; ENZYMATIC CREATININE FLEX® REAGENT CARTRIDGE

Catalog Number DF270B

Device Problem Low Test Results (2458)

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

Event Date 02/09/2014

Event Type  malfunction  

Event Description

Biased low enzymatic creatinine (ezcr) results were obtained on qc samples at two days time after calibration.It is unknown if patient results were reported to the physicians during the period of low qc recoveries.It is unknown if patient treatment was altered or prescribed on the basis of biased low ezcr results during the period of low qc recoveries.There was no report of adverse health consequences as a result of the biased low ezcr results.

Manufacturer Narrative

Analysis of the instrument and instrument data indicate that the cause for the biased low ezcr results is user error.Review of the instrument software revealed that phosphorus and enzymatic creatinine reagent cartridges were being stored on the same instruments at the same time.The account failed to follow the instruction provided with the urgent medical device correction communication (b)(4) to not run ezcr and phos reagent cartridges on the same dimension instrument.Siemens healthcare diagnostics inc.Has confirmed customer complaints of falsely depressed enzymatic creatinine (ezcr) results when ezcr is processed from open wells of enzymatic creatinine (ezcr) flex reagent cartridges that are in close proximity to open wells of phosphorus (phos) flex reagent cartridges.The falsely depressed ezcr results are caused by a ezcr reagent interaction with the phos reagent.An urgent medical device correction for the phos flex reagent cartridge (df61), communication # (b)(4) was issued in february 2013 to impacted customers.The communication provided remedial actions to customers to either avoid the reagent interactions or to discontinue the use of either phos or ezcr on their dimension system.The account was on the list of accounts notified of the workaround.

• Brand Name: DIMENSION(R) CLINICAL CHEMISTRY SYSTEM
• Type of Device: ENZYMATIC CREATININE FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19702
• 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: 3671095
• MDR Text Key: 4321416
• Report Number: 2517506-2014-00043
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K073055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Medical Technologist
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 08/08/2014
• Device Catalogue Number: DF270B
• Device Lot Number: EA4220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/08/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2517506-02-22-2013-002-C
• Patient Sequence Number: 1