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 2017-08-14 for DIMENSION XPAND PLUS W/ HM ANALYZER manufactured by Siemens Healthcare Diagnostics Inc..
[82689726]
A siemens healthcare diagnostics inc. (siemens) customer service engineer (cse) was dispatched to the customer site to inspect the system. The cse consulted with the siemens regional support center and was advised to replace the lamp, replace the r2 probe and check all alignments, check the r2 ultrasonics, replace the r2 - 500 ul metering syringe motor lead screw, replace the sample - 100 ul metering motor lead screw, perform two separate 10 minute bleach cleanings of r1 and r2 drains. The cause of the discordant mbi results is unknown. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[82689727]
A falsely high discordant creatine kinase mb isoenzyme (mbi) patient sample test result was obtained on a dimension xpand plus w/ hm system. The initial result was not reported to the physician(s). The same sample was repeated on the same system. The repeat result was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant falsely elevated mbi result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00651 |
| MDR Report Key | 6792731 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-14 |
| Date of Report | 2017-08-14 |
| Date of Event | 2017-07-19 |
| Date Mfgr Received | 2017-07-24 |
| Device Manufacturer Date | 2008-04-22 |
| Date Added to Maude | 2017-08-14 |
| 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 | KARL AEBIG |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243102 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | REGISTRATION #: 1226181 101 SILVERMINE ROAD |
| Manufacturer City | BROOKFIELD DE 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 W/ HM ANALYZER |
| Generic Name | DIMENSION XPAND PLUS W/ HM ANALYZER |
| Product Code | JHW |
| Date Received | 2017-08-14 |
| 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 197146101 US 197146101 |
| Brand Name | DIMENSION XPAND PLUS W/ HM ANALYZER |
| Generic Name | DIMENSION XPAND PLUS W/ HM ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-14 |
| 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 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-14 |