HER2 CISM PHARMDX KIT SK109

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2014-01-16 for HER2 CISM PHARMDX KIT SK109 manufactured by Dako Denmark A/s.

Event Text Entries

[16804232] Weak and heterogeneous red signals have been observed in specific lots of her2 cish pharmdx kit and reported by (b)(6) customers and internal dako customer. Reduced activity of one batch of the enzyme-antibody conjugate was identified as the root cause of weak red signals, and this specific batch was used in the cish antibody mix (vial 8) of her2 cish pharmdx kit, code (b)(4), lot number 00092789 and 20002057 not distributed in the usa and lot 20000910, distributed in the u. S.. There are no complaints of weak staining have been submitted on lot 2000090. With correct user control very low risk is associated with this product. Incorrect or absent quality control by the user prior to enumeration of stained slides will trigger the risk. According to instructions for use red and blue signals need to be clear, well balanced in intensity, distinct and easy to evaluate on the stained slide prior to enumeration of red and blue signals. No evidence that patients were misdiagnosed. If enumeration is done in situations where quality control was not followed, fewer red signals may be found. A reduced number of red signals lead to a reduced her2/cen-17 signal ratio, and weakly amplified cases may be falsely interpreted as non-amplified by this error.
Patient Sequence No: 1, Text Type: D, B5


[16967044] Her2 cish pharmdx kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the her2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine her2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The cish procedure is automated using dako autostainer instruments. Her2 cish pharmdx kit is indicated as an aid in the assessment of patients for whom herceptin (trastuzumab) treatment is being considered.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9610099-2014-00007
MDR Report Key3581659
Report Source01
Date Received2014-01-16
Date of Report2014-01-13
Date of Event2013-12-13
Date Mfgr Received2013-12-13
Device Manufacturer Date2013-10-01
Date Added to Maude2014-04-18
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 FDA0
Event Location0
Manufacturer ContactJETTE JYELDAL
Manufacturer Street42 PRODUKTIONSVEJ
Manufacturer CityGLOSTRUP DK-2600
Manufacturer CountryDA
Manufacturer PostalDK-2600
Manufacturer Phone1676098
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHER2 CISM PHARMDX KIT
Generic NameCHROMOGENIC IN SITU HYBRIDIZATION
Product CodeNYQ
Date Received2014-01-16
Model NumberSK109
Catalog NumberSK109
Lot Number20002057
Device Expiration Date2014-07-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDAKO DENMARK A/S
Manufacturer AddressGLOSTRUP DK-2600 DA DK-2600


Patients

Patient NumberTreatmentOutcomeDate
10 2014-01-16

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