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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 Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2017
Event Type  Malfunction  
Manufacturer Narrative

The customer contacted the siemens customer care center (ccc). The cause of the discordant amm results is unknown. 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 us 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 has confirmed that the customer was on the mailing list of the umdr letter and has confirmed that they received the letter in december and stated that they discarded their inventory of the affected lots. However, they received a new shipment of lot ea7223 and placed the lot in use. Siemens is currently investigating the root cause of this issue.

 
Event Description

A discordant low ammonia (amm) result was obtained on a patient sample on the dimension exl system. The flagged below assay range patient result was reported to the physician who questioned the result. The same sample was repeated on the same instrument and an alternate dimension exl and on a diluted sample and flagged below assay range results were obtained. When the same sample was repeated on an alternate instrument methodology, a higher result was obtained and reported. There are no reports of patient intervention or adverse health consequences as a result of the discordant low amm result.

 
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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 po box 6101
newark DE 19714 6101
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
glasgow business community
500 gbc drive po box 6101
newark DE 19714 6101
Manufacturer Contact
james morgera
glasgow business community
500 gbc drive po box 6101
newark, DE 19714-6101
3026318356
MDR Report Key6423873
MDR Text Key70556000
Report Number2517506-2017-00234
Device Sequence Number1
Product Code JIF
Combination Product (Y/N)N
Reporter Country CodeSP
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
Report Date 03/22/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/22/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/11/2017
Device Catalogue NumberDF119 SMN 10711991
Device LOT NumberEA7223
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 Received03/02/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/11/2016
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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