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

Catalog Number DF270B

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 03/19/2015

Event Type  malfunction  

Manufacturer Narrative

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 cartridge that is in close proximity to open wells of phosphorous (phos) flex® reagent cartridge.The falsely depressed ezcr results are caused by a phos reagent vapor interaction with the ezcr reagent.An urgent medical device correction for the phos flex® reagent cartridge (df61), communication #13-03, 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® clinical chemistry system.Siemens has confirmed that the customer received the communication.There is a note in ezcr® reagent cartridge carton, instructing users not run ezcr and phos on the same dimension® system.The note also contains a reference to the february, 2013 communication.Siemens has determined that the customer was running phos on the system at the time of the obtaining depressed urine creatinine qc results.A revised phosphorous method (df61a) which does not impact ezcr was introduced in december, 2014.The customer was sent the revised phosphorous method (df61a) and has instituted use of the revised phos df61a but has continued to use their remaining inventory of df61 for urine creatinine testing.This account has reported the potential for reporting depressed urine creatinine results by keeping both ezcr and phos df61 reagent cartridges on their dimension xpand instrument system.The account as instituted a practice of aborting the use of an ezcr reagent well set when qc is out of laboratory range and moving to a new reagent well set and repeating qc.If qc was within range, patient specimens were run as single samples.There is no record of any patient impact known at this time.The instrument is performing within specifications.

Event Description

Falsely depressed urine creatinine (ezcr) results were obtained on quality control samples.It is unknown if patient results were reported to the physician.The is no indication of change in patient patient treatment on the basis of depressed ezcr results.There was no report of adverse health consequences as a result of depressed ezcr results.

• Brand Name: DIMENSION® 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 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: 5078954
• MDR Text Key: 26244188
• Report Number: 2517506-2015-00200
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Remedial Action: Recall
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 08/09/2015
• Device Catalogue Number: DF270B
• Device Lot Number: BD5223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/09/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-1049-2013
• Patient Sequence Number: 1