PRISM CHAGAS 07K35-68

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 2012-04-25 for PRISM CHAGAS 07K35-68 manufactured by Abbott Laboratories.

Event Text Entries

[2750382] The customer stated a blood donor generated initial and repeat reactive results of 1. 35, 1. 76 and 1. 70 s/co on the prism chagas assay but did not confirm by ripa and was also nonreactive on an alternate screening method. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5


[9961407] (b)(4). Customer complaints received to-date were reviewed and did not identify any adverse trend in reports related to false reactive results. In addition, field data was reviewed to evaluate clinical specificity. The results of the field data review demonstrated that lot # 09900m500 is performing as intended for clinical specificity as measured by reactive rates. Based on the results of this investigation, the abbott prism chagas reagents, list number 7k35-68, are performing as intended and no additional product issues were identified. The customer was referred to the prism chagas package insert under limitations of the procedure for further information.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1415939-2012-00166
MDR Report Key2548458
Report Source05
Date Received2012-04-25
Date of Report2012-04-05
Date of Event2012-03-06
Date Mfgr Received2012-04-05
Device Manufacturer Date2011-11-01
Date Added to Maude2012-09-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL TECHNOLOGIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactNOEMI ROMERO-KONDOS, RN BSN
Manufacturer Street100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3
Manufacturer CityABBOTT PARK IL 600643537
Manufacturer CountryUS
Manufacturer Postal600643537
Manufacturer Phone847937-512
Manufacturer G1ABBOTT LABORATORIES
Manufacturer Street100 ABBOTT PARK ROAD
Manufacturer CityABBOTT PARK IL 60064350
Manufacturer CountryUS
Manufacturer Postal Code60064 3500
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRISM CHAGAS
Product CodeMIU
Date Received2012-04-25
Catalog Number07K35-68
Lot Number09900M500
Device Expiration Date2012-08-20
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT LABORATORIES
Manufacturer Address100 ABBOTT PARK ROAD ABBOTT PARK IL 60064350 US 60064 3500


Patients

Patient NumberTreatmentOutcomeDate
10 2012-04-25

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