MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-06-19 for VERSACELL SAMPLE MANAGEMENT SYSTEM manufactured by Siemens Healthcare Diagnostics Inc..
[5806852]
The operator of a versacell sample management system incorrectly assigned a sample identification number to a patient sample. Patient sample (b)(6) was initially loaded into the sample drawer, scanned, queried, and delivered to a dimension instrument for testing. The operator then front loaded a different patient sample and assigned the same patient sample identification (b)(6) to the specimen, which was delivered to an alternate dimension instrument for testing. The incorrect results of the specimen which was front loaded were reported to the physician(s). The results were corrected and reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the incorrect assignment of a patient identification number.
Patient Sequence No: 1, Text Type: D, B5
[13378025]
The customer contacted the siemens customer care center (ccc). Ccc reviewed the versacell log and confirmed that the operator front loaded the sample with an incorrect identification number. The cause of the incorrect assignment of a patient identification number was due to user error. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2015-00037 |
| MDR Report Key | 4856119 |
| Report Source | 05,06 |
| Date Received | 2015-06-19 |
| Date of Report | 2015-05-27 |
| Date of Event | 2015-05-27 |
| Date Mfgr Received | 2015-05-27 |
| Date Added to Maude | 2015-07-16 |
| 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 | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | 62 FLANDERS BARTLEY RD |
| Manufacturer City | FLANDERS NJ 07836 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07836 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERSACELL SAMPLE MANAGEMENT SYSTEM |
| Generic Name | CLINICAL CHEMISTRY GENERAL PURPOSE LABORATORY EQUIPMENT |
| Product Code | CDN |
| Date Received | 2015-06-19 |
| Model Number | VERSACELL SAMPLE MANAGEMENT SYSTEM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 62 FLANDERS BARTLEY RD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-19 |