MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-16 for DIMENSION VISTA? CLINICAL CHEMISTRY SYSTEM K7052 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[2792893]
A discordant low immunoglobulin a (iga) result was reported on a patient sample. The result was reported to the physician who questioned the result. The patient was tested by an alternate methodology (electrophoresis) and elevated results were obtained. The original sample was retested and an elevated result was obtained and reported. It is unknown if patient treatment was altered or prescribed. There is no report of adverse outcome to the patient as a result of initial falsely depressed iga result.
Patient Sequence No: 1, Text Type: D, B5
[10227231]
Analysis of the instrument and instrument data indicate that the cause for the falsely depressed iga result is unknown. The dimension vista(r) iga flex(r) reagent cartridge ifu in the limitations of "procedure section states: ""the iga method has been designed to minimize antigen excess in the initial sample dilution. However, it cannot be completely eliminated and in rare cases very high immunoglobulin concentrations may produce falsely-low results. Monoclonal immunoglobulins may show reactivity different from the polyclonal calibrator, which in isolated cases may lead to artificially decreased or non-linear results. "" the instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2012-00009 |
| MDR Report Key | 2701813 |
| Report Source | 05,06 |
| Date Received | 2012-08-16 |
| Date of Report | 2012-07-31 |
| Date of Event | 2012-07-25 |
| Date Mfgr Received | 2012-07-31 |
| Device Manufacturer Date | 2011-09-08 |
| Date Added to Maude | 2012-12-04 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | 76 EMIL VON BEHRING STRASSE |
| Manufacturer City | MARBURG, 35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA? CLINICAL CHEMISTRY SYSTEM |
| Generic Name | IMMUNOGLOBULIN A FLEX? REAGENT CARTRIDGE |
| Product Code | CFQ |
| Date Received | 2012-08-16 |
| Catalog Number | K7052 |
| Lot Number | 11251MA |
| Device Expiration Date | 2013-03-01 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Address | 76 EMIL VON BEHRING STRASSE MARBURG, 35041 GM 35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-16 |