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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS SIEMENS AMM AMMONIA RGT REF #DF119

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SIEMENS SIEMENS AMM AMMONIA RGT REF #DF119 Back to Search Results
Lot Number BC6258
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/09/2016
Event Type  Malfunction  
Event Description

We get an "abnl assay" next to qc or patient results. When the report prints out, you get a flag "abnl assay". This flag means you cannot report the test for qc or patients. In order to fix this problem, we take the reagent flex off the analyzer and put it back on, and we rerun the qc or patient (because it flats randomly on the qc or patient result).

 
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Brand NameSIEMENS AMM
Type of DeviceAMMONIA RGT REF #DF119
Manufacturer (Section D)
SIEMENS
newark DE 19714
MDR Report Key5434029
MDR Text Key38386630
Report NumberMW5060148
Device Sequence Number1
Product Code JIF
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 02/09/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/09/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device EXPIRATION Date09/14/2016
Device LOT NumberBC6258
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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