MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-04 for HARVEST ( LIS) manufactured by Orchard Software Corporation.
[16865122]
Two patient samples from the sample rack were run on the advia 120 analyzer. The operator stated that the sid and the patient name matched correctly in their laboratory information system (lis) but was different on the advia 120 analyzer runscreen. The patient names on the runscreen were supplied from the facility's lis. The operator noticed the mismatch with the patients name and did not repeat the samples but instead matched the samples by the position on the rack and runscreen with sid and patient name from the lis system. There are no known reports of adverse health consequences due to the system barcode reader having misread the sample barcodes.
Patient Sequence No: 1, Text Type: D, B5
[17083424]
After analyzing the instrument data, the siemens field service engineer (fse) determined that the instrument is performing within specifications. The mismatch of the patients id on the run screen report was caused by the lis sending patient id's that exceeds 14 characters as required by the product labeling instructions. The instrument is performing within specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00142 |
| MDR Report Key | 2559523 |
| Report Source | 05,06 |
| Date Received | 2012-05-04 |
| Date of Report | 2012-04-12 |
| Date of Event | 2012-04-11 |
| Date Mfgr Received | 2012-04-12 |
| Device Manufacturer Date | 2007-04-04 |
| Date Added to Maude | 2012-09-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LORIANN RUSSO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242287 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | MANUFACTURING LIMITED CHAPEL LANE |
| Manufacturer City | SWORD CO., DUBLIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARVEST ( LIS) |
| Generic Name | ORCHARD SOFTWARE CORPORATION, PRODUCT CODE: GKL |
| Product Code | GKL |
| Date Received | 2012-05-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORCHARD SOFTWARE CORPORATION |
| Manufacturer Address | 701 CONGRESSIONAL BOULEVARD SUITE 360 CARMEL IN 46032 US 46032 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-04 |