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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION® DIMENSION® AMM AMMONIA FLEX® REAGENT CARTRIDGE

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SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION® DIMENSION® AMM AMMONIA FLEX® REAGENT CARTRIDGE Back to Search Results
Catalog Number DF119 SMN 10711991
Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/14/2016
Event Type  Malfunction  
Manufacturer Narrative

The customer contacted the siemens customer care center (ccc). The cause of the discordant amm results is unknown. Siemens is investigating the issue. Note: the foreign account is in the country of (b)(6) which is not a dropdown option.

 
Event Description

Discordant low ammonia (amm) results were obtained on a patient sample on the dimension exl system. The patient results were not reported to the physician. The account regarded the initial result as discordant. It is unknown if corrected results were reported. There is no indication that patient treatment was altered or prescribed on the basis of the discordant amm results. There was no report of adverse health consequences as a result of the discordant amm results.

 
Manufacturer Narrative

Original mdr 2517506-2016-00497 was filed 2016-12-07. (b)(4) siemens healthcare diagnostics is conducting a recall for the dimension® ammonia flex® reagent cartridge/amm df119 (smn # 10711991) kit lots (fb7152, eb7180, ba7194, ea7223, ba7250) and dimension vista® ammonia flex® reagent cartridge / amm k3119 (smn #10711992) kit lots (16187be, 16225bb, 16265ab). Siemens healthcare diagnostics has determined that dimension amm (df119) flex reagent cartridge lots fb7152, eb7180, ba7194, ea7223, ba7250 and dimension vista amm (k3119) flex reagent cartridge flex lots 16187be, 16225bb, 16265ab do not meet the 60-day calibration interval claim due to reagent instability and results may show an abnormal assay. These lots may exhibit accuracy shifts for patient and/or quality control results; which may cause laboratories to recalibrate more frequently than the 60-day claim in the instructions for use (ifu). An urgent field safety notices (ufsn's) dc17-01. A. Ous. Dm and dc 17. 01a. Ous. Dmv were sent to ous customers and an urgent medical device recalls (umdr's) dc17-01. A. Us. Dm and dc 17. 01a. Us. Dmv were sent to u. S. Customers in december 2016. The ufsn and umdr informs the customers to discontinue use of and discard the affected kit lot. Siemens recommends using an alternate lot of dimension or dimension vista amm. Siemens is currently investigating the root cause of this issue.

 
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Brand NameDIMENSION®
Type of DeviceDIMENSION® AMM AMMONIA 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 Key6152962
MDR Text Key61736365
Report Number2517506-2016-00497
Device Sequence Number1
Product Code JIF
Combination Product (Y/N)N
PMA/PMN NumberK123320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Recall
Type of Report Initial,Followup
Report Date 01/06/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/07/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/29/2017
Device Catalogue NumberDF119 SMN 10711991
Device LOT NumberEB7180
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/29/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number2517506-12/27/2016-004-R

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