IMMULITE 2000 30002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-02-05 for IMMULITE 2000 30002 manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[18000695] The customer has obtained a false negative result on one patient sample for human chorionic gonadotropin (hcg) on an immulite 2000 instrument. The false negative result was reported to the physician and was questioned as it did not align with the clinical picture of the patient. A new sample draw was obtained from the patient and retested it on the same immulite 2000 instrument and the result was positive. The sample was then diluted and tested again and the result was positive. The initial sample was then rerun on the same immulite 2000 instrument and the result was positive. This sample was also diluted and tested on the instrument and the result was positive. The results of the new sample draw and the repeat results of the initial sample were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to false negative hcg result.
Patient Sequence No: 1, Text Type: D, B5


[18316323] A siemens field service engineer (fse) was dispatched to the customer site. The fse performed a system check and found that the substrate was overfilled and had thus overflowed into the scrubber which caused the co2 scrubber to become damaged. In addition the tubing connected to the scrubber was kinked. The fse ran a quality control check and samples recovered within specifications. The cause of the false negative hcg result 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


MAUDE Entry Details

Report Number2247117-2015-00003
MDR Report Key4487997
Report Source05,06
Date Received2015-02-05
Date of Report2015-01-16
Date of Event2015-01-08
Date Mfgr Received2015-01-16
Date Added to Maude2015-03-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactAARTI AZIZ
Manufacturer Street511 BENEDICT AVENUE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145242683
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Street62 FLANDERS BARTLEY ROAD
Manufacturer CityFLANDERS NJ 07836
Manufacturer CountryUS
Manufacturer Postal Code07836
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIMMULITE 2000
Generic NameIMMULITE 2000
Product CodeJJQ
Date Received2015-02-05
Model NumberIMMULITE 2000
Catalog Number30002
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Address62 FLANDERS BARTLEY ROAD FLANDERS NJ 07836 US 07836


Patients

Patient NumberTreatmentOutcomeDate
10 2015-02-05

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