MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-06-04 for BERICHROM(R) HEPARIN OWLD115 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[3495913]
Discrepant heparin results were obtained on qc and patient samples. The customer had been reporting results to the physician. It is unknown if results were questioned by the physicians. It was subsequently discovered that the physicians had been running unfractioned heparin tests for patients who were on low molecular weight heparin therapy. It is unknown if patient treatment was altered on the basis of the discrepant heparin results. There is no report of adverse outcome to the patients as a result of the discrepant results.
Patient Sequence No: 1, Text Type: D, B5
[10796576]
The cause of the discrepant heparin results is user (physician) error. The physicians had been running unfractioned heparin tests for patients who were on low molecular weight heparin therapy. The berichrom heparin instruction for use states: "samples must have the same type of heparin (low molecular weight or unfractionated) as the calibrator used for the reference curve. " the instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2013-00010 |
| MDR Report Key | 3145995 |
| Report Source | 05,06 |
| Date Received | 2013-06-04 |
| Date of Report | 2013-05-08 |
| Date of Event | 2013-05-08 |
| Date Mfgr Received | 2013-05-08 |
| Device Manufacturer Date | 2012-02-03 |
| Date Added to Maude | 2013-08-22 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| 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 | BERICHROM(R) HEPARIN |
| Generic Name | BERICHROM(R) HEPARIN |
| Product Code | KFF |
| Date Received | 2013-06-04 |
| Catalog Number | OWLD115 |
| Lot Number | 41486 |
| Device Expiration Date | 2014-11-21 |
| 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 | 2013-06-04 |