MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-03-02 for ADVIA 2120I N/A manufactured by Siemens Healthcare Diagnostics, Inc..
[2520712]
An incorrect patient id (pid) was reported for a sample on an advia 2120i instrument. The pid associated with the sample did not correspond to the patient name in the data manager. Only corrected results were reported to the physician. There are no known reports of adverse health consequences or patient intervention due to the incorrect pid.
Patient Sequence No: 1, Text Type: D, B5
[9651905]
Siemens technical support was contacted by the customer. After evaluation of the issue, it was determined that the patient id (pid) exceeded the limit of 14 digits as documented in the siemens manual "communications links between the data manager and a host computer". The result was that the pid of 15 digits was truncated to 14 resulting in the pid for two patients to be the same. When the data manager did a search for patient demographics, it selected the first sample that matched the truncated pid. The instrument is within specification and operational. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00054 |
| MDR Report Key | 2476209 |
| Report Source | 05,06 |
| Date Received | 2012-03-02 |
| Date of Report | 2012-02-06 |
| Date of Event | 2012-02-05 |
| Date Mfgr Received | 2012-02-06 |
| Device Manufacturer Date | 2010-04-16 |
| Date Added to Maude | 2012-08-27 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 2120I |
| Generic Name | HEMATOLOGY ANALYZER |
| Product Code | GKL |
| Date Received | 2012-03-02 |
| Model Number | ADVIA 2120I |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 23 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-02 |