MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-01-09 for ADVIA 2120 067-A004 manufactured by Siemens Healthcare Diagnostics.
[21670332]
The customer ran two patient samples with sample identification numbers ( sid) consisting of 16 characters. The advia hematology 2120 stripped the last two digits of the sid and associated the results with another patient. The results were obtained on the patients samples. The results were reported to the physician(s), no corrected reports were required. There were no reports of patient intervention or adverse health consequences due to the duplicate sample identification.
Patient Sequence No: 1, Text Type: D, B5
[21859365]
Siemens technical solution center (tsc) explained to the customer that the sample identification number can not exceed 14 characters. As stated in the advia 2120 hematology system operators guide and the host interface manual " sample identification number (14 characters maximum)'". The customer resolved the issue on their own, no field service engineer (fse) was requested. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00005 |
| MDR Report Key | 2404321 |
| Report Source | 05,06 |
| Date Received | 2012-01-09 |
| Date of Report | 2011-12-23 |
| Date of Event | 2011-12-21 |
| Date Mfgr Received | 2011-12-23 |
| Device Manufacturer Date | 2004-10-13 |
| Date Added to Maude | 2012-07-31 |
| 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 | LINDA BARLETTA |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242299 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | MANUFACTURING LIMITED, CHAPEL LANE |
| Manufacturer City | SWORD, CO. DUBLIN, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 2120 |
| Generic Name | HEMATOLOGY ANALAYZER, PRODUCT CODE: |
| Product Code | GKL |
| Date Received | 2012-01-09 |
| Model Number | ADVIA 2120 |
| Catalog Number | 067-A004 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-09 |