MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-11-22 for ICHEM VELOCITY 700-7177-001 manufactured by Iris International.
[4464730]
The same barcode was read incorrectly for two patients on two separate dates due to a malfunction. No injury, treatment or change in patient management was reported by the customer. The error was detected prior to release outside of the lab. Information pertaining to patients was not made available.
Patient Sequence No: 1, Text Type: D, B5
[11795463]
The field service engineer replaced the bar code reader, performed an alignment, completed performance verification checklist, ran controls which all passed, and discussed system performance with the operator. Customer was able to run specimens without any issues. System was operational.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023446-2013-00020 |
| MDR Report Key | 3748665 |
| Report Source | 05 |
| Date Received | 2013-11-22 |
| Date of Report | 2013-11-22 |
| Date of Event | 2013-04-16 |
| Date Mfgr Received | 2013-04-16 |
| Device Manufacturer Date | 2012-05-01 |
| Date Added to Maude | 2014-05-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUDHA GUPTA |
| Manufacturer Street | 9172 ETON AVE. |
| Manufacturer City | CHATSWORTH CA 91311 |
| Manufacturer Country | US |
| Manufacturer Postal | 91311 |
| Manufacturer Phone | 8185277497 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICHEM VELOCITY |
| Generic Name | ICHEM VELOCITY |
| Product Code | JJW |
| Date Received | 2013-11-22 |
| Model Number | 700-7177-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRIS INTERNATIONAL |
| Manufacturer Address | CHATSWORTH CA 91311 US 91311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-22 |