DIMENSION XPAND PLUS W/ HM ANALYZER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-08-14 for DIMENSION XPAND PLUS W/ HM ANALYZER manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[82689726] A siemens healthcare diagnostics inc. (siemens) customer service engineer (cse) was dispatched to the customer site to inspect the system. The cse consulted with the siemens regional support center and was advised to replace the lamp, replace the r2 probe and check all alignments, check the r2 ultrasonics, replace the r2 - 500 ul metering syringe motor lead screw, replace the sample - 100 ul metering motor lead screw, perform two separate 10 minute bleach cleanings of r1 and r2 drains. The cause of the discordant mbi results is unknown. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10


[82689727] A falsely high discordant creatine kinase mb isoenzyme (mbi) patient sample test result was obtained on a dimension xpand plus w/ hm system. The initial result was not reported to the physician(s). The same sample was repeated on the same system. The repeat result was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant falsely elevated mbi result.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2517506-2017-00651
MDR Report Key6792731
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-08-14
Date of Report2017-08-14
Date of Event2017-07-19
Date Mfgr Received2017-07-24
Device Manufacturer Date2008-04-22
Date Added to Maude2017-08-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARL AEBIG
Manufacturer Street511 BENEDICT AVE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145243102
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer StreetREGISTRATION #: 1226181 101 SILVERMINE ROAD
Manufacturer CityBROOKFIELD DE 06804
Manufacturer CountryUS
Manufacturer Postal Code06804
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameDIMENSION XPAND PLUS W/ HM ANALYZER
Generic NameDIMENSION XPAND PLUS W/ HM ANALYZER
Product CodeJHW
Date Received2017-08-14
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No0
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Address500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101

Device Sequence Number: 1

Brand NameDIMENSION XPAND PLUS W/ HM ANALYZER
Generic NameDIMENSION XPAND PLUS W/ HM ANALYZER
Product CodeJJE
Date Received2017-08-14
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Address500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101


Patients

Patient NumberTreatmentOutcomeDate
10 2017-08-14

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