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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDLAB 1260; RL 1260
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SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDLAB 1260; RL 1260 Back to Search Results
Catalog Number 10321846
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/18/2014
Event Type  malfunction  
Event Description
Customer reported discordant ionized calcium (ca++) result between the instrument and rapidlab 1265.Customer indicated that 50 patient samples were affected.There was no injury reported due to this event.
 
Manufacturer Narrative
Customer indicated that they replaced the ionized calcium sensor and results are shifter upwards back to where they are expected and more comparable to the other rl1265.Instrument is operational.
 
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Brand Name
RAPIDLAB 1260
Type of Device
RL 1260
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
511 benedict ave.
tarrytown NY 10591
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.
northern road,
chilton industry
sudbury, suffolk CO10 2XQ
UK   CO10 2XQ
Manufacturer Contact
steven andberg
2 edgewater drive
norwood, MA 02062
7812693655
MDR Report Key3687961
MDR Text Key4288021
Report Number1217157-2014-00038
Device Sequence Number1
Product Code CHL
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K031560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Medical Assistant
Device Catalogue Number10321846
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/19/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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