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 2017-03-24 for PRISM CHAGAS 07K35-68 manufactured by Abbott Laboratories.

Event Text Entries

[70890188] An evaluation is in process. A follow up report will be submitted when the evaluation is complete. See also additional reports for the same data with different suspect medical device in use: manufacturers report number 1415939-2017-00022 for lot 68048m500, manufacturers report number 1415939-2017-00023 for lot 70056m500.
Patient Sequence No: 1, Text Type: N, H10


[70890189] The customer observed multiple falsely reactive chagas blood donor specimens while using prism chagas reagents. The specimen results were repeat reactive using the prism reagents, however did not confirm. The following data was provided (s/co): chagas tests: sid (b)(6) initial 3. 47 (reactive), repeat 3. 69, 3. 86 (reactive), sid (b)(6) initial 4. 64 (reactive), repeat 5. 16, 4. 48 (reactive), sid (b)(6) initial 2. 64 (reactive), repeat 2. 49, 2. 93 (reactive), sid (b)(6) initial 4. 92 (reactive), repeat 4. 37, 5. 16 (reactive). No specific values were provided for sid (b)(6). All the units were t. Cruzi (chagas) negative using a supplemental method, with the exception of sid (b)(6) that returned an intermediate result. There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5


[73132907] Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and specificity testing. No adverse trend was identified for the customer's issue. Labeling was reviewed and found to be adequate. Clinical specificity testing of negative control replicates was performed using in-house retained kits stored at the recommended storage condition. Specificity testing met all specifications. Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1415939-2017-00027
MDR Report Key6433860
Report SourceHEALTH PROFESSIONAL
Date Received2017-03-24
Date of Report2017-04-06
Date of Event2017-01-10
Date Mfgr Received2017-04-05
Device Manufacturer Date2017-01-01
Date Added to Maude2017-03-24
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 Received2017-03-24
Catalog Number07K35-68
Lot Number70116M500
Device Expiration Date2017-09-14
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 2017-03-24

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