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 2016-11-15 for PRISM CHAGAS 07K35-68 manufactured by Abbott Laboratories.

Event Text Entries

[59976370] An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. An evaluation is in-process.
Patient Sequence No: 1, Text Type: N, H10


[59976371] The customer indicated an increase in reactive results has been generated while using the prism chagas assay on the prism 6 channel analyzer. During the timeframe of (b)(6) 2016 to (b)(6) 2016, twelve specimens which had been repeat reactive were negative when tested using the ortho method. Specifically the customer indicated that false positive results were generated on (b)(6) 2016 and (b)(6) 2016 using lot 60017m500. No specific patient data has been provided. There was no adverse impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5


[63636710] Further investigation of the customer issue included a review of the complaint text, in-house testing, a device history review, a search for similar complaints, and a review of labeling. Return material was not available from the customer. A specificity testing protocol was executed using lot 60017m500 and met acceptance criteria and determined the reagent is performing acceptably. The device history review did not identify any non-conformances or deviations related to the customer's observations. Tracking and trending did not identify an adverse trend. Labeling was reviewed and found to be adequate. Based on the available information no product deficiency of the prism chagas reagent, list number (b)(4), lot number 60017m500, was identified.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1415939-2016-00112
MDR Report Key6103038
Report SourceHEALTH PROFESSIONAL
Date Received2016-11-15
Date of Report2016-12-21
Date of Event2016-07-10
Date Mfgr Received2016-12-21
Device Manufacturer Date2016-02-01
Date Added to Maude2016-11-15
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 Received2016-11-15
Catalog Number07K35-68
Lot Number60017M500
Device Expiration Date2016-09-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
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 2016-11-15

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