MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-12-29 for BERICHROME HEPARIN OWLD 115 manufactured by Dade Behring Gmbh.
[16109424]
Falsely depressed heparin xa results were obtained on a eight pt samples. The results were reported to the physician and were questioned. Pt treatment was delayed but there was no report of adverse health consequences as a result of the falsely depressed heparin xa results. Discussion with the customer revealed that the reagent was being used past its stated on board stability.
Patient Sequence No: 1, Text Type: D, B5
[16232238]
No further evaluation of the device is required. The cause for the falsely depressed heparin xa results was the reagent being used past its on board stability. This is a use error. The instrument is operating within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2006-00004 |
| MDR Report Key | 802130 |
| Report Source | 05 |
| Date Received | 2006-12-29 |
| Date of Report | 2006-12-04 |
| Date of Event | 2006-12-03 |
| Date Mfgr Received | 2006-12-04 |
| Device Manufacturer Date | 2001-01-01 |
| Date Added to Maude | 2007-01-11 |
| 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 | 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 | BERICHROME HEPARIN |
| Generic Name | HEPARIN XA TEST |
| Product Code | KFF |
| Date Received | 2006-12-29 |
| Model Number | NA |
| Catalog Number | OWLD 115 |
| Lot Number | 541437 |
| ID Number | NA |
| Device Expiration Date | 2008-10-16 |
| 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 | 789644 |
| Manufacturer | DADE BEHRING GMBH |
| Manufacturer Address | * MARBURG GM |
| Baseline Brand Name | BARICHROME HEPARIN |
| Baseline Generic Name | HEPARIN XA TEST |
| Baseline Model No | NA |
| Baseline Catalog No | OWLD 115 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-12-29 |