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 2013-09-05 for PRISM CHAGAS 07K35-68 manufactured by Abbott Laboratories.

Event Text Entries

[3839822] The customer reports a falsely reactive prism chagas assay result on one donor sample. The sample generated an initial reactive result of 2. 65 s/co with repeat reactive results of 2. 13 and 1. 60 s/co. The sample tested negative by ripa confirmation testing. The customer noted that their initial reactive (. 032%) and repeat reactive rates (0. 23%) for (b)(6) 2013 exceeded assay package insert claims of 0. 28% and 0. 22% respectively. The customer noted that there were no changes in their testing process. The majority of samples were fresh serum with possibly a few fresh plasma samples. All donors were being tested for the first time for chagas. The customer stated that the current and previous reagent lots have had no issues and are performing as expected. No suspect results had been reported from the lab with no donor impact.
Patient Sequence No: 1, Text Type: D, B5


[10923308] An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. (b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[26492915] The evaluation of complaint data for the prism chagas assay lot 23242m501 did not identify any atypical activity. A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. A review of the lot device history records did not reveal any issues related to the observations made by the customer. Also, a review of the prism metrics field data indicates that lot 23242m501 (including base lot) is meeting labeling claims for clinical specificity. No performance issues were identified. The prism chagas assay package insert contains information to address the current customer issue. Based on the results of the current evaluation, a product malfunction was not identified.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1415939-2013-00335
MDR Report Key3327939
Report Source05
Date Received2013-09-05
Date of Report2013-08-20
Date of Event2013-07-27
Date Mfgr Received2013-09-30
Device Manufacturer Date2013-01-01
Date Added to Maude2013-12-04
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 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 Received2013-09-05
Catalog Number07K35-68
Lot Number23242M501
Device Expiration Date2013-09-27
OperatorOTHER
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 60064350 US 60064 3500


Patients

Patient NumberTreatmentOutcomeDate
10 2013-09-05

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