MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-02 for PARATA SYSTEMS DRUG DISPENSING MACHINE manufactured by Parata Systems.
[1739279]
(b)(6) and evidently many other pharmacies use a parata systems machine to dispense and label common drugs. The labels fade away within a short time so that drug name, dosage and prescript # are no longer readable. I complained but got no satisfaction. The only recourse is to request that the label be covered with tape each time a prescription is filled. The obvious dangers include patients not being able to differentiate between pills, taking the wrong pills at the wrong times, taking multiple doses etc etc. The elderly are particularly at risk!! These machines are everywhere and the risk is enormous! Many drugs look alike. So how many hundreds of thousands of people are out there who may be taking over-dosages, or skipping important meds because they can't read their labels? Dates of use: 2009 to present. Diagnosis or reason for use: prescription drug purchases.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018049 |
| MDR Report Key | 1893117 |
| Date Received | 2010-11-02 |
| Date Added to Maude | 2010-11-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARATA SYSTEMS DRUG DISPENSING MACHINE |
| Generic Name | NONE |
| Product Code | NXB |
| Date Received | 2010-11-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PARATA SYSTEMS |
| Manufacturer Address | MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2010-11-02 |