MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2002-08-30 for INTEGRA FERRITIN 753556 manufactured by Rd Gmbh.
[258101]
Some sera may under-recover ferritin by up to 35% in the range of 100 mg/ml to 500 ng/ml. Under-recovery is caused by a sample specific matrix effect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2002-00273 |
| MDR Report Key | 414575 |
| Report Source | 07 |
| Date Received | 2002-08-30 |
| Date of Report | 2002-08-27 |
| Date of Event | 2002-08-22 |
| Date Mfgr Received | 2002-08-22 |
| Date Added to Maude | 2002-09-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DEBARA REEK |
| Manufacturer Street | 9115 HAGUE ROAD |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175763857 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTEGRA FERRITIN |
| Generic Name | CLINICAL CHEMISTRY REAGENT |
| Product Code | DBF |
| Date Received | 2002-08-30 |
| Model Number | NA |
| Catalog Number | 753556 |
| Lot Number | ALL |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 403614 |
| Manufacturer | RD GMBH |
| Manufacturer Address | SANDOFER STRASSE 116 MANNHEIM US D-68305 |
| Baseline Brand Name | INTEGRA FERRITIN |
| Baseline Generic Name | CLINICAL CHEMISTRY REAGENT |
| Baseline Model No | NA |
| Baseline Catalog No | 753556 |
| Baseline ID | NA |
| Baseline Device Family | FERRITIN |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 18 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K963292 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-08-30 |