MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-09-18 for MULTIFIBRIN U OWZG-15 manufactured by Dade Behring Gmbh.
[699112]
A falsely depressed fibrinogen result of less than or equal to 50 mg/dl was obtained on a patient sample. The result was reported to the physician. The patient was treated with 2 units of cryoprecipitate. Another sample was tested post treatment and a result of less than or equal to 50 mg/dl was obtained. The same sample was repeated by alternate methodology and a result of 545 mg/dl was obtained. The patient was treated with 2 units of cryoprecipitate. There was no report of adverse health consequences to the patient as a result of the treatment. Analysis of the instrument and instrument data indicate that the instrument was performing within specifications. The hospital pathologist concluded that the cause for the falsely depressed fibrinogen was interference from the patient's multiple myeloma proteins.
Patient Sequence No: 1, Text Type: D, B5
[7875874]
No further evaluation of the device is required. Analysis of the instrument and instrument data indicate that the instrument was performing within specifications. The hospital pathologist concluded that the cause for the falsely depressed fibrinogen was interference from the patient's multiple myeloma proteins.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2007-00011 |
| MDR Report Key | 916291 |
| Report Source | 05 |
| Date Received | 2007-09-18 |
| Date of Report | 2007-08-29 |
| Date of Event | 2007-08-24 |
| Date Mfgr Received | 2007-08-29 |
| Device Manufacturer Date | 2007-07-28 |
| Date Added to Maude | 2007-10-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CAROLYN CHASTAIN |
| Manufacturer Street | P.O. BOX 6101 M/S 514 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318789 |
| Manufacturer G1 | DADE BEHRING GMBH |
| Manufacturer Street | 76 EMIL-VON-BEHRING STRASSE |
| Manufacturer City | MARBURG |
| Manufacturer Country | GM |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTIFIBRIN U |
| Generic Name | FIBRINOGEN REAGENT |
| Product Code | KQJ |
| Date Received | 2007-09-18 |
| Model Number | NA |
| Catalog Number | OWZG-15 |
| Lot Number | 519829 |
| ID Number | NA |
| Device Expiration Date | 2008-05-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 899374 |
| Manufacturer | DADE BEHRING GMBH |
| Manufacturer Address | MARBURG GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-09-18 |