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 health professional report with the FDA on 2016-11-21 for PRISM CHAGAS 07K35-68 manufactured by Abbott Laboratories.

Event Text Entries

[60660043] An evaluation is in process. A followup report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10


[60660044] The account generated false repeatedly reactive prism chagas results on 20 donors that tested esa chagas negative since (b)(6) 2016. Additionally, 5 donors were prism chagas were repeatedly reactive but no confirmatory testing was available since january 2016. No impact to patient management was reported. No specific donor information was available.
Patient Sequence No: 1, Text Type: D, B5


[65847061] Evaluation of complaint data for the products and likely cause lot identified normal complaint activity. Additionally, review of the device history records for the likely cause lot did not reveal any issues related to the customer's observations. Label reviews were also performed and found them to adequately address the customer's issue. Finally, review of the prism metrics field data indicates that the initial and repeat reactive rates for the abbott prism chagas products are less than the package insert upper 95% confidence intervals. Therefore, the lots are meeting labeling claims for clinical specificity. There is no malfunction or product deficiency. The abbott prism chagas products are performing acceptably.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1415939-2016-00115
MDR Report Key6118950
Report SourceHEALTH PROFESSIONAL
Date Received2016-11-21
Date of Report2017-01-17
Date Mfgr Received2016-12-21
Device Manufacturer Date2016-09-01
Date Added to Maude2016-11-21
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 ContactNOEMI ROMERO-KONDOS, RN BSN
Manufacturer Street100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3
Manufacturer CityABBOTT PARK IL 600643537
Manufacturer CountryUS
Manufacturer Postal600643537
Manufacturer Phone224667-512
Manufacturer G1ABBOTT LABORATORIES
Manufacturer Street100 ABBOTT PARK ROAD
Manufacturer CityABBOTT PARK IL 600643500
Manufacturer CountryUS
Manufacturer Postal Code600643500
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRISM CHAGAS
Generic NameCHAGAS
Product CodeMIU
Date Received2016-11-21
Catalog Number07K35-68
Lot Number64065M500
Device Expiration Date2017-01-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT LABORATORIES
Manufacturer Address100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US 600643500


Patients

Patient NumberTreatmentOutcomeDate
10 2016-11-21

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