MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-01-30 for UF-1000I WITH URINALYSIS WAM manufactured by Sysmex.
[3130660]
Pt demographic transcription error with urinalysis system wam software. There was no report of injury with this event.
Patient Sequence No: 1, Text Type: D, B5
[10521299]
Customer reported that when running a pt sample, the auwi analyzer auto verified incorrect pt results. The customer claims that the sample was not tested on the auwi and there are no results in either the atlas or uf1000i ipu. Results exist in the wam software for the pt with the original accession number (b)(4) however the results are incorrect and were reported to the physician. The customer created a new accession number (b)(4) for the same sample and tested it on the auwi and obtained different results that were reported to the physician and the incorrect reported results amended. The mfr of the software has identified an error in the software that causes data to be overwritten with prior reported results due to an invalid yr being populated in the "century break" field.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2012-00086 |
| MDR Report Key | 2982801 |
| Report Source | 07 |
| Date Received | 2013-01-30 |
| Date of Report | 2012-08-09 |
| Date of Event | 2012-08-09 |
| Date Mfgr Received | 2012-08-09 |
| Date Added to Maude | 2013-04-17 |
| 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 | MARK SMITH |
| Manufacturer Street | 2 EDGEWATER DR. |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693158 |
| Manufacturer G1 | SYSMEX |
| Manufacturer Street | 577 APTAKISIC RD |
| 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 | 2013-01-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYSMEX |
| Manufacturer Address | 577 APTAKISIC RD LINCOLNSHIRE IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-30 |