MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-04-11 for UF-1000I WITH URINALYSIS WAM 10379707 manufactured by Sysmex.
[21982616]
Customer reported that a bacteria result of 1+ was reported as ns (not seen). Customer reported that they confirmed all results by microscopy. There was no report of injury for this event.
Patient Sequence No: 1, Text Type: D, B5
[22336759]
The cause for the discordant bacteria results was due to a miss-configured rule. This has been corrected and the system is operating as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2013-00056 |
| MDR Report Key | 3071034 |
| Report Source | 07 |
| Date Received | 2013-04-11 |
| Date of Report | 2013-03-26 |
| Date of Event | 2013-03-26 |
| Date Mfgr Received | 2013-03-26 |
| Date Added to Maude | 2013-04-30 |
| 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 | STEVE ANDBERG |
| Manufacturer Street | 2 EDGEWATER DR. |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693655 |
| Manufacturer G1 | SYSMEX |
| Manufacturer Street | 577 APTAKISIC ROAD |
| Manufacturer City | LINCOLNSHIRE IL 60069 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60069 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UF-1000I WITH URINALYSIS WAM |
| Generic Name | UF-1000I |
| Product Code | LKM |
| Date Received | 2013-04-11 |
| Catalog Number | 10379707 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYSMEX |
| Manufacturer Address | 577 APTAKISIC ROAD LINCOLNSHIRE IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-11 |