MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-07-20 for PATHROMTIN SL 10446066 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[80657654]
The operator contacted a siemens healthcare diagnostics inc. (siemens) technical application specialist (tas) to determine which result they should report for activated partial thromboplastin time (aptt) and whether the pathromtin sl reagent can be used to monitor low-molecular weight (lmw) heparin therapy. The operator indicated that they routinely use the actin fsl reagent to test for aptt and they use the pathromtin sl reagent specifically to test heparinized patients and for this patient they obtained different results when they tested the patient's blood in parallel using the pathromtin sl and actin fsl reagents. The operator did not provide the lot numbers of the pathromtin sl and actin fsl reagents. Siemens has determined that actin fsl and pathromtin sl reagents are not recommended for monitoring of aptt when the patient is on low-molecular weight (lmw) heparin therapy. The instruction for use (ifu) for the actin fsl and pathromtin sl reagents do not have performance claims for monitoring lmw heparin therapy. Siemens offers four different aptt reagents which provide options in sensitivity to heparin, lupus anticoagulants, and factor deficiencies that allows customers to select a reagent type that is most appropriate for monitoring their specific patient population. The variation in sensitivity can lead to differences in the aptt results on patient samples. The instrument and reagents are performing according to specifications. No further evaluation of this device is required. Mdr 9610806-2017-00072 and mdr 9610806-2017-00073 were filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[80657655]
A patient was administered low-molecular weight (lmw) heparin therapy after receiving surgery and tested for activated partial thromboplastin time (aptt). In parallel, the operator analyzed the patient blood for aptt using the actin fsl and pathromtin sl reagents and obtained different aptt results. The operator obtained an aptt result of 152 seconds using the pathromtin sl reagent and obtained an aptt result of 30 seconds using the actin fsl reagent. It is unknown if any results were reported to the physician. The operator indicated they explained the situation to the physician such that these aptt results did not affect the patient. The operator indicated that the physician treated the patient according to standard medical protocols and other test results. There are no known reports of patient intervention or adverse health consequences due to the different aptt results obtained between the pathromtin sl and actin fsl reagents.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00074 |
| MDR Report Key | 6730214 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-20 |
| Date of Report | 2017-07-31 |
| Date of Event | 2017-06-06 |
| Date Mfgr Received | 2017-07-21 |
| Date Added to Maude | 2017-07-20 |
| 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 | 3 |
| Manufacturer Contact | ELIZABETH BERNASCONI |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242495 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL-VON-BEHRING-STR. 76 |
| Manufacturer City | D-35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATHROMTIN SL |
| Generic Name | PATHROMTIN SL |
| Product Code | GFO |
| Date Received | 2017-07-20 |
| Model Number | PATHROMTIN SL |
| Catalog Number | 10446066 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| 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 | EMIL-VON-BEHRING- STR. 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-20 |