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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION® DIMENSION® EXL WITH LM INTEGRATED CHEMISTRY SYSTEM

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SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION® DIMENSION® EXL WITH LM INTEGRATED CHEMISTRY SYSTEM Back to Search Results
Model Number DIMENSION® EXL WITH LM
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/10/2017
Event Type  Malfunction  
Manufacturer Narrative

The customer contacted the siemens customer care center (ccc). The cause of the discordant amm results is unknown. The issue was resolved by replacement of the flex reagent cartridge with an alternate amm flex reagent cartridge lot and repeat testing. Siemens is investigating the incident.

 
Event Description

Discordant low ammonia (amm) results were obtained on a patient sample on the dimension exl system. The patient result was not reported to the physician. The sample was rerun on the same sample on the same instrument after a flex reagent cartridge change and a higher result was obtained and reported. There are no reports of patient intervention or adverse health consequences as a result of the discordant amm results.

 
Manufacturer Narrative

Original mdr 2517506-2017-00135 was filed 2/7/2017. Siemens healthcare diagnostic headquarters support center evaluated the incident and concluded their investigation. The cause of the discordant low ammonia results is unknown. There was only one patient sample affected. The data logs from the instrument were analyzed. The low results were processed using flex lot fa7096. There was no indication in the data logs of reagent delivery, foaming, or hemolysis interference based on result monitors for the tests processed using either lot fa7096 or the flex lot fa7123 used for the repeat tests. No systemic instrument or reagent malfunction was confirmed. The instrument is performing within specifications. No further evaluation of the device is required.

 
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Brand NameDIMENSION®
Type of DeviceDIMENSION® EXL WITH LM INTEGRATED CHEMISTRY SYSTEM
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- BROOKFIELD
registration number 1226181
101 silvermine road
brookfield CT 06804
Manufacturer Contact
james morgera
glasgow business community
500 gbc drive po box 6101
newark, DE 19714-6101
3026318356
MDR Report Key6307017
MDR Text Key66681551
Report Number2517506-2017-00135
Device Sequence Number0
Product Code JIF
Combination Product (Y/N)N
Reporter Country CodeSP
PMA/PMN NumberK130276
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 03/24/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/07/2017
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDIMENSION® EXL WITH LM
Device Catalogue NumberSMN 10472176
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 Manufactured04/11/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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