MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-03-01 for DIMENSION XPAND WITH HM manufactured by Siemens Healthcare Diagnostics Inc..
[68774449]
The customer contacted a siemens customer care center (ccc) specialist. The ccc specialist reviewed the data provided. The customer's quality control (qc) was in range at the time of the event. The ccc reviewed the system's counters, which were within specifications. The ccc reviewed the system checks data, which was in range. The customer cleaned system windows and noticed that they accessed "bad" and was prompted to clean 25 windows, which were not dirty. A siemens headquarters support center (hsc) specialist reviewed the event. Hsc reviewed the instrument data. Hsc did not find any errors or issues with the instrument. The issue was isolated to this specific sample. The cause of the discordant, falsely depressed cholesterol result is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[68774450]
A discordant, falsely depressed cholesterol result was obtained on a patient sample on a dimension xpand with hm instrument. The initial result was reported out to the physician(s), which were questioned. The customer repeated the same sample on the same dimension xpand with hm instrument, resulting higher. The customer issued a corrected report to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed cholesterol results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00213 |
| MDR Report Key | 6371079 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-01 |
| Date of Report | 2017-03-01 |
| Date of Event | 2017-01-27 |
| Date Mfgr Received | 2017-02-02 |
| Device Manufacturer Date | 2009-04-09 |
| Date Added to Maude | 2017-03-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TIMOTHY RICE |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242406 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | REGISTRATION NUMBER: 1226181 101 SILVERMINE ROAD |
| Manufacturer City | BROOKFIELD CT 06804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION XPAND WITH HM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CHH |
| Date Received | 2017-03-01 |
| Model Number | DIMENSION XPAND WITH HM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 19714 US 19714 |
| Brand Name | DIMENSION XPAND WITH HM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-03-01 |
| Model Number | DIMENSION XPAND WITH HM |
| 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 | 500 GBC DRIVE PO BOX 6101 NEWARK DE 19714 US 19714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-01 |