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 2017-02-28 for DIMENSION XPAND WITH HM manufactured by Siemens Healthcare Diagnostics Inc..
[68608818]
A siemens' customer service engineer (cse) was dispatched to the customer's site. The cse evaluated the instrument. The cse did not find any instrument issues or errors associated with the event. Siemens is investigating the event.
Patient Sequence No: 1, Text Type: N, H10
[68608819]
A discordant, falsely elevated tacrolimus 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 was questioned. The customer repeated the same sample at another site, resulting lower. A corrected reported was not issued to the physician(s). There are no known reports of adverse health consequences due to the discordant, falsely elevated tacrolimus results.
Patient Sequence No: 1, Text Type: D, B5
[73372001]
The initial mdr 2517506-2017-00216 was filed on (b)(6) 2017. Additional information (03/08/2017): a siemens headquarters support center (hsc) reviewed the event. Hsc found no issues with the instrument. The instrument performed as intended. Hsc reviewed the patient's history of results and found the patient's elevated tacrolimus results were repeatable on multiple sample collections. Elevated tacrolimus values were obtained on the plasma from the patient sample. Testing plasma samples for tacrolimus should recover values below assay range because the tacrolimus is bound to protein within the red cell. This pattern of tacrolimus recovery is consistent with a non-specific interferent in the patient sample. The cause of the discordant, falsely elevated tacrolimus results is due to a non-specific interferent in the patient sample. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2017-00216 |
| MDR Report Key | 6366578 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-28 |
| Date of Report | 2017-03-30 |
| Date of Event | 2017-01-17 |
| Date Mfgr Received | 2017-03-08 |
| Device Manufacturer Date | 2009-02-24 |
| Date Added to Maude | 2017-02-28 |
| 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 | MLM |
| Date Received | 2017-02-28 |
| Model Number | DIMENSION XPAND 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 19714 US 19714 |
| Brand Name | DIMENSION XPAND WITH HM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-02-28 |
| Model Number | DIMENSION XPAND 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 19714 US 19714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-28 |