MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-02-09 for IRIS IQ 200 SPRINT ANAL manufactured by Iris Diagnostics Division.
[1014431]
Urinalysis was completed an sperm was found in the urine on analysis. It was later believed that a previous specimen had sperm that had carryovered to the next two specimens. Upon conferring with the manufacturer, it was determined that the machine has had in issue with sperm carryover.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1311143 |
| MDR Report Key | 1311143 |
| Report Source | 99 |
| Date Received | 2009-02-09 |
| Date of Report | 2009-02-03 |
| Date of Event | 2009-01-03 |
| Date Facility Aware | 2009-01-05 |
| Report Date | 2009-01-07 |
| Date Reported to FDA | 2009-02-03 |
| Date Reported to Mfgr | 2009-01-07 |
| Date Added to Maude | 2009-02-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IRIS |
| Generic Name | IQ SERIES ANALYZER |
| Product Code | JJW |
| Date Received | 2009-02-09 |
| Model Number | IQ 200 SPRINT ANAL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRIS DIAGNOSTICS DIVISION |
| Manufacturer Address | 9172 EATON AVE. CHATSWORTH CA 91311 US 91311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-09 |