MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-03-29 for BEHRICHORM(R) HEPARIN OWLD115 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[16910197]
A customer complains of a high berichrom(r) heparin result relative to a result obtained by an alternate methodology. The customer states that the berichrom heparin elevated result was accepted on a patient sample and alleges it led to a decision to change the heparin treatment of the patient. The patient suffered a stroke.
Patient Sequence No: 1, Text Type: D, B5
[16931108]
The cause of the discrepancy versus the alternate methodology is unknown. Correlation to the alternate assay is not established. The complaint is under investigation by siemens healthcare diagnostics.
Patient Sequence No: 1, Text Type: N, H10
[34401705]
Original mdr was filed 2013-03-29. Further investigation confirmed that the basis of the customer complaint was customer correlation to an alternate assay which is not established or claimed by siemens healthcare diagnostics. At the time of the complaint, the berichrom heparin control results were within the qc control ranges. Siemens assessment showed that user processed the sample with a modified application (change of washing step) and reported a value reported above the calibrated range. Therefore, a clear link of the insult to the heparin measurement cannot be drawn. In addition, differences between the methods discussed is known from proficiency trials and reflects several technical and design differences. Additionally, evaluation of the berichrom(r) heparin product, owld, was conducted relative to complaints of low recoveries with reagent time on board the instrument. It was concluded that if a change of heparin level is observed during on board stability, it will be shown by a lower control recovery. It is extremely unlikely that an erroneously low heparin value may be reported which may trigger a higher dose of heparin therapy which could slightly increase the risk of bleeding. The potential of an adverse event to the patient is considered to be very unlikely because only the lower therapeutic range is affected. (in this instance which is unrelated to on board stability, discrepant elevated results were alleged).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2013-00006 |
| MDR Report Key | 3027571 |
| Report Source | 01,05,06 |
| Date Received | 2013-03-29 |
| Date of Report | 2013-10-07 |
| Date of Event | 2013-03-18 |
| Date Mfgr Received | 2013-10-07 |
| Device Manufacturer Date | 2012-02-24 |
| Date Added to Maude | 2013-03-29 |
| 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 | 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 INC - GLASGOW |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE |
| Manufacturer City | NEWARK DE 19702350 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19702 3504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BEHRICHORM(R) HEPARIN |
| Generic Name | BEHRICHORM(R) HEPARIN |
| Product Code | KFF |
| Date Received | 2013-03-29 |
| Catalog Number | OWLD115 |
| Lot Number | 41523 |
| Device Expiration Date | 2014-11-21 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Other | 2013-03-29 |