MEDICAL COMPUTERS AND SOFTWARE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-03 for MEDICAL COMPUTERS AND SOFTWARE manufactured by Unk.

Event Text Entries

[129937392] I have been highly sensitive to all food dyes deemed safe by the fda since i was in my early 20's. I first found out when i was pregnant with my first child. My symptoms when and if i ingest or have skin contact is angina, and lately, a-fib, shortness of breath and weakness. I have told all my medical providers about this sensitivity. I have xxxxx as my most used pharmacy. I am on (b)(6) and have xxxxx as pharmaceutical insurance. I have repeatedly informed xxxxx of the issue and told them i am allergic to fda approved food dyes. In the past, they have sent me white acyclovir as requested. Recently they sent me pink colored acyclovir. I called them last week and they said they would send white acyclovir out overnight delivery. When i was on the phone with them last week i told them the name of the mfr of the acyclovir that they need to use. I talked first with a xxxx customer care rep, then a pharmacy tech and then they had me talk with a pharmacist. They said they were sorry for the mistake and would correct it immediately and send out the correct medication. It has been week later i have not received the correct acyclovir. Not good 7:15 am thursday (b)(6). Medication administered to or used by the pt: no. When and how was error discovered? I opened the medication bottle. I think the software that these pharmacies use, should have the capability to include allergies that are not the normal ones, ie pcn, etc. If the software that they purchased was more flexible, then these errors may not happen. The tech, who is filling the prescription has no idea about an uncommon sensitivity or allergy because it is not flagged. At one of my local pharmacy i dealt with, they had to include "white pills only" as my middle name so the tech would know how to fill the prescription. I have had this issue for a long, long time and i am worried that as i get older, and may get incapacitated, i may not be able to monitor the mistakes the pharmacies make. I wish the it companies that design this type of software for the pharmacies would get the message that people have uncommon allergies that are dangerous and that there should be an accommodation made in the software for that issue. (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5081824
MDR Report Key8129305
Date Received2018-12-03
Date of Report2018-10-18
Date of Event2018-01-01
Date Added to Maude2018-12-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationUNKNOWN
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMEDICAL COMPUTERS AND SOFTWARE
Generic NameMEDICAL COMPUTERS AND SOFTWARE
Product CodeLNX
Date Received2018-12-03
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-03

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