MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-07-03 for BERICHROM(R) HEPARIN OWLD115 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[15021487]
A discrepant low heparin result was obtained on a qc sample. The sample was repeated with a freshly reconstituted reagent vial and recovery for the sample was within range. Patient treatment was not altered or prescribed on the basis of the discrepant heparin qc result. There is no report of adverse outcome to patients as a result of the discrepant qc result.
Patient Sequence No: 1, Text Type: D, B5
[15415238]
The cause of the discrepant heparin qc result is under investigation. The berichrom(r) heparin product, owld, remains under investigation relative to the on board stability claim by siemens healthcare diagnostics inc. A contributing factor may have been instrumentation issues with the bcs xp instrument. A siemens healthcare diagnostics field service engineer was dispatched to the account and found a failed reagent piston pump and replaced it. They also replaced a bypass valve and two leaking tubings.
Patient Sequence No: 1, Text Type: N, H10
[34342232]
Original mdr was filed 2013-07-03. Further investigation confirmed that the primary cause of the discrepant low heparin results obtained on a qc sample was the instrumentation issues. A siemens healthcare diagnostics field service engineer was dispatched to the account and conducted appropriate repairs. Additionally, evaluation of the berichrom heparin product, owld, was conducted. 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. (as it was in this instance) 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2013-00014 |
| MDR Report Key | 3204795 |
| Report Source | 05,06 |
| Date Received | 2013-07-03 |
| Date of Report | 2013-10-07 |
| Date of Event | 2013-06-04 |
| Date Mfgr Received | 2013-10-07 |
| Device Manufacturer Date | 2013-02-21 |
| Date Added to Maude | 2013-09-27 |
| 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 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 |
| Remedial Action | RP |
| 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 | 2013-07-03 |
| Catalog Number | OWLD115 |
| Lot Number | 42569 |
| Device Expiration Date | 2015-11-11 |
| 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 | 2013-07-03 |