MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-12-22 for N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG) OSAS SMN10446298 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[63108098]
Analysis of the instrument and instrument data indicate that the cause for the discordant low csf igg result was antigen excess. The issue was resolved by repeating the sample at a higher dilution as described in the reagent instructions for use. The n antiserum to human igg instructions for use describes the scenario in the limitations of procedure section. The immunoglobulin assays have been designed to minimize antigen excess in the initial sample dilutions. However, it cannot be completely eliminated and in rare cases very high immunoglobulin concentrations may produce falsely-low results. Especially monoclonal immunoglobulins may show reactivity different from the polyclonal standard, which in isolated cases may lead to artificially decreased or non-linear results. In case of serum or plasma determinations, the constellation of igg, iga and igm should be assessed. A check of igg results in csf should be performed by means of ratio diagrams. In case of questionable results, the determinations should be repeated using the next higher sample dilution. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[63108099]
A discordant low igg result was obtained on a patient spinal fluid (csf) sample on the bn prospec instrument. The patient result was not reported to the physician. The laboratory repeated the same sample at a higher dilution and a higher result was obtained and reported. Patient treatment was not altered or prescribed based on the initial discordant low csf igg result. There is no indication of any adverse health consequences due to the initial discordant low csf igg result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2016-00046 |
| MDR Report Key | 6198574 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-12-22 |
| Date of Report | 2016-12-22 |
| Date of Event | 2016-11-22 |
| Date Mfgr Received | 2016-11-25 |
| Device Manufacturer Date | 2016-08-02 |
| Date Added to Maude | 2016-12-22 |
| 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 | 3 |
| Event Location | 3 |
| 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 | EMIL VON BEHRING STRASSE 76 |
| Manufacturer City | MARBURG, D-35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG) |
| Generic Name | N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG) |
| Product Code | CFN |
| Date Received | 2016-12-22 |
| Catalog Number | OSAS SMN10446298 |
| Lot Number | 153025F |
| Device Expiration Date | 2018-07-18 |
| Operator | HEALTH PROFESSIONAL |
| 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 | EMIL VON BEHRING STRASSE 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-22 |