IMMULITE 2000 CMV IGM L2KCM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-09-12 for IMMULITE 2000 CMV IGM L2KCM manufactured by Siemens Healthcare Diagnostics Products, Limited.

Event Text Entries

[54508343] Siemens healthcare diagnostics has confirmed increased imprecision on some patient samples with the immulite? /immulite? 1000 cmv igm reagent lots 330 and 331 and on the immulite? 2000 / immulite? 2000 lots 255, 256, 257, 258, 259, 260, 261, 262, 263, 264, 266, and 267. These samples may exhibit higher percent coefficient of variation (% cv) than the precision performance data published in the instructions for use (ifu) across (b)(6), indeterminate, and (b)(6) ratios. Quality controls provided in the cmv igm kit may not detect the imprecision with patient results. An urgent field safety notice (ufsn) imc 16-22a. Ous was sent out to customers and an urgent medical device recall (umdr) imc16-22. A. Us was sent to us customers in august 2016. The ufsn and umdr informs the customers to discontinue use of and discard the affected kit lots listed above. Siemens recommends transitioning to immulite 2000/2000 xpi cmv igm kit lots 268 and above and immulite 1000 kit lot 332 and above.
Patient Sequence No: 1, Text Type: N, H10


[54508344] The customer has indicated that they are obtaining increased (b)(6) results for igm antibodies to (b)(6) assay on an immulite 2000 xpi instrument when using kit lots 259 and 260. The customer had 9. 32% of (b)(6) results. The customer moved the (b)(6) testing to an alternate laboratory. It is unknown which results were reported to the physician(s). There were no reports of patient intervention or adverse health consequences due to results.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2432235-2016-00512
MDR Report Key5943884
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2016-09-12
Date of Report2016-09-12
Date of Event2016-03-02
Date Mfgr Received2016-08-22
Date Added to Maude2016-09-12
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 Location3
Manufacturer ContactELIZABETH BEATO
Manufacturer Street511 BENEDICT AVENUE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145243074
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
Manufacturer StreetREGISTRATION #: 3002806944 GLYN RHONWY
Manufacturer CityLLANBERIS, GWYNEDD, LL554EL
Manufacturer CountryUK
Manufacturer Postal CodeLL55 4EL
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number2432235-08/31/2016-001-R
Event Type3
Type of Report3

Device Details

Brand NameIMMULITE 2000 CMV IGM
Generic NameIMMULITE 2000 CMV IGM
Product CodeLKQ
Date Received2016-09-12
Model NumberIMMULITE 2000 CMV IGM
Catalog NumberL2KCM
Lot Number259/260
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
Manufacturer AddressREGISTRATION #: 3002806944 GLYN RHONWY LLANBERIS, GWYNEDD, LL554EL UK LL55 4EL


Patients

Patient NumberTreatmentOutcomeDate
10 2016-09-12

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