DAKO IR055

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2015-08-14 for DAKO IR055 manufactured by Dako North America, Inc.

Event Text Entries

[23089775] On (b)(6) 2015, dako received a complaint regarding the routine use of the flex monoclonal mouse anti-human wilms' tumor 1 (wt1) protein clone 6f-h2 on the autostainer link 48 for diagnostic use. Initially the customer reported false positive staining, claiming that this staining contributed to a diagnostic error leading to distress, unnecessary surgery and other incorrect treatment. On august 12, 2015, dako received follow up information regarding this incident. The customer reported that they have revalidated the same batch of wt1 used in the original testing and have confirmed expected staining results. The customer reported that a retest was also carried out at another laboratory, on sections from the same biopsy, and results were also positive. The customer reported that a separate test can on surgical test resection tissue done at another hospital was negative. The customer reported that as a result of these conclusions, the customer has informed dako that they are no longer pursuing a complaint about dako regarding false positive staining with the wt1 antibody. Dako is in the process of obtaining details of this complaint for further investigation.
Patient Sequence No: 1, Text Type: D, B5


[35017446] Follow-up: after further investigation, dako has discovered that the problem complaint described in this mdr, 2022180-2015-0002, had nothing to do with the wt1 antibody. The issue was discovered to be related to the envision flex+ product problem that was outlined in mdr 9610099-2015-2015. This investigation is closed.
Patient Sequence No: 1, Text Type: N, H10


[35017447] Please see additional manufacture narrative.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2022180-2015-00002
MDR Report Key5004603
Report SourceFOREIGN
Date Received2015-08-14
Date of Report2015-11-03
Date Mfgr Received2015-07-16
Device Manufacturer Date2014-03-27
Date Added to Maude2015-08-14
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 ContactASHLEIGH DAWLEY
Manufacturer Street6392 VIA REAL
Manufacturer CityCARPINTERIA CA 93013
Manufacturer CountryUS
Manufacturer Postal93013
Manufacturer Phone8055663072
Manufacturer G1DAKO NORTH AMERICA, INC
Manufacturer Street6392 VIA REAL
Manufacturer CityCARPINTERIA CA 93013
Manufacturer CountryUS
Manufacturer Postal Code93013
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDAKO
Generic NameFLEX MONOCLONAL MOUSE (WT1) PROTEIN CLONE 6F-H2, RTU, LINK
Product CodeNJT
Date Received2015-08-14
Model NumberIR055
Catalog NumberIR055
Lot Number10086975
Device Expiration Date2015-09-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerDAKO NORTH AMERICA, INC
Manufacturer Address6392 VIA REAL CARPINTERIA CA 93013 US 93013


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-08-14

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