PANTHER SYSTEM 902615

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-03 for PANTHER SYSTEM 902615 manufactured by Hologic, Inc..

Event Text Entries

[69373039] Grifols' customer, (b)(6) reported during an ultrio elite assay run, that sample (b)(6) was misread as (b)(6) by the panther instrument. Customer identified this issue when the laboratory information system (lis) did not have a result for the sample (b)(6). At that time, they discovered the panther instrument misread as (b)(6). The number created by the panther did not exist in site as a donor system record. No incorrect result was reported out. Hologic sw team confirmed the issue was not software related but a possible firmware issue. Panther supplier was notified and further investigation is ongoing.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024800-2017-00009
MDR Report Key6378241
Date Received2017-03-03
Date of Report2017-03-03
Date of Event2017-01-10
Date Mfgr Received2017-08-31
Date Added to Maude2017-03-03
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 ContactMS. JULIETTE BUSSE
Manufacturer Street10210 GENETIC CENTER DRIVE
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal92121
Manufacturer Phone8584108799
Manufacturer G1HOLOGIC, INC.
Manufacturer Street10210 GENETIC CENTER DRIVE
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal Code92121
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePANTHER SYSTEM
Generic NameIN VITRO DIAGNOSTICS
Product CodeMKZ
Date Received2017-03-03
Catalog Number902615
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerHOLOGIC, INC.
Manufacturer Address10210 GENETIC CENTER DR. SAN DIEGO CA 92121 US 92121


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-03-03

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