MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-02-12 for DIMENSION VISTA 500 manufactured by Siemens Healthcare Diagnostics Inc.
[4128702]
A discordant potassium (k) result was obtained on a dimension vista 500 instrument for one patient. The discordant k result was reported to the physician, who questioned the result. The patient was drawn a second time under sample id (b)(6) and tested on (b)(6) 2014, yielding normal results. Additionally, the laboratory retrieved and reran the original sample, also yielding normal results. The patient was admitted to the hospital based on the initial falsely elevated k result and was treated for renal failure with insulin. There are no other known reports of adverse health consequences due to the discordant k result.
Patient Sequence No: 1, Text Type: D, B5
[11685879]
A siemens technical service consultant (tsc) was contacted by the customer. The tsc evaluated the instrument data and did not find an instrument malfunction. The tsc determined that the sample was centrifuged using statspin for 3 minutes at 8500 rpms and was outside of the tube vendors manufacturer's instructions for use (ifu) for centrifugation at 1300 rpms for 10 minutes. The tsc instructed the customer to follow the tube vendor's ifu and to follow the proper pre-analytical sample handling procedures. The cause of the discordant potassium result is unknown. The instrument is performing within specifications. Further evaluation of the device is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226181-2014-00070 |
| MDR Report Key | 3625663 |
| Report Source | 05,06 |
| Date Received | 2014-02-12 |
| Date of Report | 2014-01-18 |
| Date of Event | 2014-01-17 |
| Date Mfgr Received | 2014-01-18 |
| Device Manufacturer Date | 2012-05-07 |
| Date Added to Maude | 2014-05-05 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN NELSON |
| Manufacturer Street | SIEMENS HEALTHCARE DIAGNOSTICS 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | 101 SILVERMINE ROAD |
| Manufacturer City | BROOKFIELD CT 06804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06804 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA 500 |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | MZV |
| Date Received | 2014-02-12 |
| Model Number | DIMENSION VISTA 500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Address | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-12 |