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 2017-03-02 for DIMENSION EXL WITH LM manufactured by Siemens Healthcare Diagnostics Inc..
[68980276]
A siemens customer care center (ccc) specialist was contacted by the customer. The ccc reviewed the data provided. The ccc found the chemistry wash was low. The customer replaced the chemistry wash and primed the wash ten times. The customer replaced a new flex and ran quality control (qc) level 1 five times, resulting within range. The cause of the discordant, falsely elevated creatine kinase mb results is due to low chemistry wash. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[68980277]
Discordant, falsely elevated creatine kinase mb results were obtained on one patient sample on a dimension exl with lm instrument. The initial result was not reported out to the physician(s). The customer repeated the same sample on the same dimension exl with lm instrument, resulting lower. The customer repeated the same sample on the same dimension exl instrument again, resulting lower than the original but flagged with a process error. The customer repeated the same sample on the same instrument two more times, resulting with an "abnormal reaction" flag. It is unknown if the customer reported out any results to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated creatine kinase mb results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00221 |
| MDR Report Key | 6374566 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-02 |
| Date of Report | 2017-03-02 |
| Date of Event | 2017-02-05 |
| Date Mfgr Received | 2017-02-05 |
| Device Manufacturer Date | 2013-10-18 |
| Date Added to Maude | 2017-03-02 |
| 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 EXL WITH LM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JHW |
| Date Received | 2017-03-02 |
| Model Number | DIMENSION EXL WITH LM |
| 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 EXL WITH LM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-03-02 |
| Model Number | DIMENSION EXL WITH LM |
| 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 | 1. Other | 2017-03-02 |