BOND ORACLE HER2 IHC SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-02-10 for BOND ORACLE HER2 IHC SYSTEM manufactured by Leica Biosystems Newcastle Ltd..

Event Text Entries

[38379346] A review of the results and further testing by the healthcare professional demonstrated 3 pts samples may have given a false negative result. On 23rd january 2016, (b)(4) were given the following info: pt 1: (b)(6), female, mdr number: 3004859032-2016-00001. Pt 2: (b)(6), female, mdr number: 3004859032-2016-00002. Pt 3: (b)(6), female, mdr number: 3004859032-2016-00003. Mdr 3004859032-2015-00002 was raised following the complaint. The report has been ongoing as the investigation required further info from the customer.
Patient Sequence No: 1, Text Type: N, H10


[38379347] (b)(4) was informed on september 14, 2015 that 2 batches of bond oracle her2 ihc system - product code ta9145 (lots 27595 and 20871) were used for testing pt samples.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004859032-2016-00002
MDR Report Key5440961
Report SourceCOMPANY REPRESENTATIVE
Date Received2016-02-10
Date of Report2016-01-23
Date of Event2015-09-14
Date Mfgr Received2015-09-14
Date Added to Maude2016-02-17
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 StreetBALLIOL BUSINESS PARK WEST BENTON LANE
Manufacturer CityNEWCASTLE
Manufacturer CountryUK
Manufacturer Phone912154736
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBOND ORACLE HER2 IHC SYSTEM
Generic NameNONE
Product CodeMVC
Date Received2016-02-10
Lot Number20871 AND 27595
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerLEICA BIOSYSTEMS NEWCASTLE LTD.
Manufacturer AddressBALLIOL BUSINESS PARK WEST BENTON LANE NEWCASTLE NE128EW UK NE12 8EW


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2016-02-10

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