MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-04-20 for DIMENSION XPAND PLUS WITH HM manufactured by Siemens Healthcare Diagnostics Inc..
[73228727]
The customer contacted the ccc specialist and stated that they inadvertently tested an infant patient sample without a small sample container. Quality controls on the day of the event were within acceptable range. The sample from the patient was collected in a tube. However, the operator should have put a sample cup container with the whole blood sample on top of the specimen collection tube for tacrolimus processing. The issue was resolved by repeating tracrolimus testing for the sample by placing the sample container cup on top of the tube. The cause of the discordant, falsely low tacrolimus results was due to the sample not being processed with the sample cup container. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[73228728]
The customer of a dimension xpand plus with hm instrument contacted a siemens customer care center (ccc) and stated that they inadvertently tested an infant patient sample without a small sample container (ssc). As a result, discordant, falsely low tacrolimus results were obtained upon initial and repeat testing. The discordant results were reported to the physician(s). The physician increased the dosage of tacrolimus due to the falsely low results. The customer repeated the sample twice with the small sample container on the same instrument, resulting higher both times. The corrected results were reported to the physician(s). There are no reports of adverse health consequence due to the discordant, falsely low tacrolimus results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00411 |
| MDR Report Key | 6506946 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-20 |
| Date of Report | 2018-03-26 |
| Date of Event | 2017-03-23 |
| Date Mfgr Received | 2018-03-21 |
| Device Manufacturer Date | 2009-09-11 |
| Date Added to Maude | 2017-04-20 |
| 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 | SHWETA GULATI |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242870 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | REGISTRATION #: 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 PLUS WITH HM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | MLM |
| Date Received | 2017-04-20 |
| Model Number | DIMENSION XPAND PLUS WITH HM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 197146101 US 197146101 |
| Brand Name | DIMENSION XPAND PLUS WITH HM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-04-20 |
| Model Number | DIMENSION XPAND PLUS WITH HM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-20 |