ALLSET GOLD A HIGH RES SSP 54010D

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-07-10 for ALLSET GOLD A HIGH RES SSP 54010D manufactured by Life Technologies.

Event Text Entries

[24646741] The investigation replicated the customer's observation (b)(6) 2015. The investigation concluded on 06/16/2015 and was unable to determine whether the result is related to the specific dna sample or reflective or incorrect labeling on the reactivity for the allele.
Patient Sequence No: 1, Text Type: N, H10


[24646742] This report is related to customer complaint ci23108 made against allset gold a high res ssp (sku 54010d, lot 012 1608823), since this lot (listed in c. 6. ) contains the same affected primer mix. The customer reported that the reactivity for lane 86 was negative for the a 03:20 allele when the labeling indicates the reactivity should be positive. The labeling discrepancy may lead to potentially mistyping an a 03:20 allele as an a 03:01 allele.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2244574-2015-00092
MDR Report Key4912900
Report Source05
Date Received2015-07-10
Date of Report2015-05-22
Date of Event2015-02-22
Device Manufacturer Date2013-10-02
Date Added to Maude2015-07-23
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 ContactTHOMAS TYRE
Manufacturer Street9099 NORTH DEERBROOK TRAIL
Manufacturer CityBROWN DEER WI 53223
Manufacturer CountryUS
Manufacturer Postal53223
Manufacturer G1INVITROGEN CORPORATION
Manufacturer Street9099 NORTH DEERBROOK TRAIL
Manufacturer CityBROWN DEER WI 53223
Manufacturer CountryUS
Manufacturer Postal Code53223
Single Use3
Remedial ActionRB
Previous Use Code3
Removal Correction Number2244574-008-2015 C
Event Type3
Type of Report3

Device Details

Brand NameALLSET GOLD A HIGH RES SSP
Generic NameTEST, QUALITATIVE FOR HLA
Product CodeMZI
Date Received2015-07-10
Catalog Number54010D
Lot Number012 1446993
Device Expiration Date2015-03-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerLIFE TECHNOLOGIES
Manufacturer AddressBROWN DEER WI US


Patients

Patient NumberTreatmentOutcomeDate
10 2015-07-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.