MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-05-02 for DIMENSION EXL WITH LM manufactured by Siemens Healthcare Diagnostics.
[4444189]
A discordant potassium (k) result was obtained on one patient sample on a dimension exl with lm instrument. The discordant k result was reported to the physician(s), who questioned it. The customer reran the sample (1st repeat) on the same instrument and that result was reported to the physician(s). The customer repeated the sample later that day (2nd repeat) on the same instrument, which resulted lower. The sample was also repeated (3rd repeat) on an alternate system, which resulted lower. These results were reported to the physician(s). The patient was redrawn and the sample was tested on an alternate system, which resulted lower. The corrected result was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant k results.
Patient Sequence No: 1, Text Type: D, B5
[11849708]
The siemens customer care center (ccc) was contacted by the customer. The ccc evaluated the instrument data and instructed the customer to check the integrated multisensor technology (imt) pumping rate and to replace the quiklyte sensor. The ccc recommended that the customer ensure tubes are full draws, to prevent platelets from forming, which can cause elevated potassium results on initial aspiration. The cause of the elevated potassium results is unknown. The customer successfully ran precision and qc. The instrument is performing within specifications. Further evaluation of the device is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226181-2014-00242 |
| MDR Report Key | 3788016 |
| Report Source | 05,06 |
| Date Received | 2014-05-02 |
| Date of Report | 2014-04-09 |
| Date of Event | 2014-04-04 |
| Date Mfgr Received | 2014-04-09 |
| Device Manufacturer Date | 2011-05-18 |
| Date Added to Maude | 2014-06-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN NELSON |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD |
| Manufacturer Street | 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 SYSTEM |
| Product Code | MZV |
| Date Received | 2014-05-02 |
| Model Number | DIMENSION EXL WITH LM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-02 |