DIMENSION EXL WITH LM

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 2017-08-28 for DIMENSION EXL WITH LM manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[83973925] The customer contacted a siemens customer care center. Quality controls were within acceptable range. The customer cleaned the cuvette windows, performed photometer arm alignment, cleaned sample and reagent 1 drains, checked sample and reagent 1 alignments, switched to a new reagent well, and performed calibration, however, the issue still persisted. A customer service engineer (cse) was dispatched to the customer site. The cse checked the probe alignments. The customer used another lot to repeat the patient results, which were acceptable. A siemens headquarters support center (hsc) specialist reviewed the instrument data, which indicated sample mix issues. The ccc specialist followed up with the customer, who stated that the results were acceptable after installing the new lot number and calibrating with the new calibrator. The customer performed correlation study using old and new reagent lot and the results were different. The customer believes that the issue was due to the instability of reagent lot number ea8145 on eco2. The hsc specialist further reviewed the instrument data and stated that the lamp mili amplifier unit on the empty cuvette was suggesting a problem with the source lamp. The calibration mili amplifier unit for eco2 reagent lot ea8145 is consistent with the newer lot ea8172 with acceptable quality control performance ruling out a reagent problem with lot ea8145. The hsc specialist recommended that the customer replaces the source lamp. The customer declined hsc's recommendations to replace the source lamp and is declining to use lot ea8145. The hsc specialist stated that changes in recovery after a calibration that adjusts with re-calibration are likely due to continued deterioration of the source lamp being calibrated into the calibration. The hsc specialist concluded that eco2 lot ea8145 is working as specified. The cause of the discordant eco2 results on patient samples is unknown. The instrument is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10


[83973926] The customer obtained discordant enzymatic carbonate (eco2) results on patient samples on a dimension exl with lm instrument. The customer provided an example of a discordant result on a patient sample, which was falsely elevated. The initial result was not reported to the physician(s). After calibration, the sample was repeated on the same instrument, resulting lower. The repeat result was reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant eco2 results.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2517506-2017-00673
MDR Report Key6825472
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-08-28
Date of Report2017-08-28
Date of Event2017-08-07
Date Mfgr Received2017-08-07
Device Manufacturer Date2015-05-26
Date Added to Maude2017-08-28
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 CT 06804
Manufacturer CountryUS
Manufacturer Postal Code06804
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameDIMENSION EXL WITH LM
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeCHS
Date Received2017-08-28
Model NumberDIMENSION EXL WITH LM
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 EXL WITH LM
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeJJE
Date Received2017-08-28
Model NumberDIMENSION EXL WITH LM
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 2017-08-28

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