MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-03-08 for BERICHROM OWLD 11 manufactured by Dade Behring Marburg Gmbh.
[593065]
Customer has reported stability problems with berichrome heparin xa when run in sample cups. Initial results on five pts were questioned by the pharmacist, and repeat results on the same samples with fresh reagents have confirmed that the pts are adequately heparinized. Therefore, no adverse health consequence has been reported for any of these pts. This is non-standard use since reagent should be run from the original reagent vials. The instructions for use defines the stability of the reagent in the original reagent vial.
Patient Sequence No: 1, Text Type: D, B5
[7818598]
No further evaluation of the device is required. Analysis of the instrument and instrument data indicate that the cause of the falsely depressed heparin xa results was user error. Customer poured reagent in sample cups. This is non-standard use. The instructions for use defines the stability of the reagent in the original reagent vial. The instrument is operating within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2007-00003 |
| MDR Report Key | 831161 |
| Report Source | 05 |
| Date Received | 2007-03-08 |
| Date of Report | 2007-02-16 |
| Date of Event | 2007-02-07 |
| Date Mfgr Received | 2007-02-16 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2007-03-28 |
| 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 | 0 |
| Manufacturer Contact | EDWARD SZYMANSKI, PH.D |
| Manufacturer Street | P.O. BOX 6101 M/S 514 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026317672 |
| 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 | BERICHROM |
| Generic Name | HEPARIN XA |
| Product Code | KFF |
| Date Received | 2007-03-08 |
| Model Number | NA |
| Catalog Number | OWLD 11 |
| Lot Number | 541437 |
| ID Number | NA |
| Device Expiration Date | 2009-05-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 818497 |
| Manufacturer | DADE BEHRING MARBURG GMBH |
| Manufacturer Address | * MARBURG GM |
| Baseline Brand Name | BERICHROM |
| Baseline Generic Name | HEPARIN XA |
| Baseline Model No | NA |
| Baseline Catalog No | OWLD 11 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-03-08 |