MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION® 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 10/28/2015

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 df61.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 incident.A revised phosphorous method (df61a) which does not impact ezcr was introduced in december, 2014.The customer has the revised phosphorous method (df61a) in their inventory but had not converted to the new method yet.The instrument is performing within specifications.

Event Description

Falsely depressed enzymatic creatinine (ezcr) results were obtained on patient samples.The results were not reported to the physician.The samples were repeated on a new set of reagent wells and higher results were obtained consistent with prior results on the patients.Patient treatment was not altered or prescribed on the basis of the falsely depressed creatinine results.There was no report of adverse health consequences as a result of the falsely depressed creatinine 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: 5250915
• MDR Text Key: 32156091
• Report Number: 2517506-2015-00212
• 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
• Type of Report: Initial
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 04/07/2015
• Device Catalogue Number: DF270B
• Device Lot Number: DA6098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/06/2015
• 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