MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-11-30 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc.
[2958562]
A discordant result for acetaminophen (actm) was obtained on a dimension vista 1500 instrument. The result was high and automatically repeated, resulting in a high result. The result was reported out and questioned by the physician(s). The customer reran the sample on another instrument in the laboratory and obtained a low result which was consistent with patient history. A corrected result report was sent to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant high actm result.
Patient Sequence No: 1, Text Type: D, B5
[10260834]
The siemens technical support center (tsc) analyzed the database of the instrument. The tsc found excess of protein in the sample. The cause of the discordant actm result is inknown. The instrument is performing within specifications. Further evaluation of the device is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226181-2012-00138 |
| MDR Report Key | 2853430 |
| Report Source | 05,06 |
| Date Received | 2012-11-30 |
| Date of Report | 2012-11-05 |
| Date of Event | 2012-11-01 |
| Date Mfgr Received | 2012-11-05 |
| Date Added to Maude | 2013-03-07 |
| 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 | MR. MICHAEL METZ |
| Manufacturer Street | SIEMENS HEALTHCARE DIAGNOSTICS 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242223 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA 1500 |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | LDP |
| Date Received | 2012-11-30 |
| Model Number | DIMENSION VISTA 1500 |
| Lot Number | 12205BE |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2012-11-30 |