MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-05-10 for BN PROSPEC OQTH manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[3498122]
Falsely depressed ferritin results were obtained on 3 patient samples. The results were reported to the physician who questioned the results. Patient treatment was not altered or prescribed on the basis of the falsely depressed ferritin results. There is no report of adverse patient impact as a result of the falsely depressed ferritin results.
Patient Sequence No: 1, Text Type: D, B5
[10770206]
The cause of the falsely depressed ferritin results is unknown. Internal studies by siemens healthcare of the lot in the complaint did not confirm a reagent issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2013-00007 |
| MDR Report Key | 3106407 |
| Report Source | 01,05,06 |
| Date Received | 2013-05-10 |
| Date of Report | 2013-04-11 |
| Date of Event | 2013-04-10 |
| Date Mfgr Received | 2013-04-11 |
| Device Manufacturer Date | 2012-12-14 |
| Date Added to Maude | 2013-07-17 |
| 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 | 0 |
| 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 | BN PROSPEC |
| Generic Name | N LATEX FERRITIN |
| Product Code | KFF |
| Date Received | 2013-05-10 |
| Catalog Number | OQTH |
| Lot Number | 169788 |
| Device Expiration Date | 2013-09-13 |
| 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 | 2013-05-10 |