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 2017-01-20 for BN PROSPEC OVLI11 SMN10461865 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[65469222]
The cause of the discordant depressed immunoglobulin g, immunoglobulin a, and immunoglobulin m (igg, iga and igm) results is unknown. The pattern of low results on multiple analytes on the same sample is suggestive of a pre-analytical sample issue. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[65469223]
Discordant depressed immunoglobulin g, immunoglobulin a, and immunoglobulin m (igg, iga and igm) results were obtained on a patient sample on the bn prospec instrument. The results were reported to the physician. The same sample was later repeated on the same instrument and higher results were obtained and reported. The initial depressed results were regarded as discordant. There is no indication that patient treatment was altered or prescribed on the basis of the discordant depressed igg, iga and igm results. There was no report of adverse health consequences as a result of the discordant depressed igg, iga and igm results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00006 |
| MDR Report Key | 6266559 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-20 |
| Date of Report | 2017-01-20 |
| Date of Event | 2016-12-21 |
| Date Mfgr Received | 2016-12-22 |
| Device Manufacturer Date | 2015-08-01 |
| Date Added to Maude | 2017-01-20 |
| 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 500 GBC DRIVE 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 | BN PROSPEC |
| Generic Name | BN PROSPEC NEPHELOMETER/PC/SOFTWARE KIT |
| Product Code | JZW |
| Date Received | 2017-01-20 |
| Catalog Number | OVLI11 SMN10461865 |
| 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 | 2017-01-20 |