MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-04-13 for DADE ACTIN FSL ACTIVATED PTT REAGENT 10445714 manufactured by Siemens Healthcare Diagnostics Product Gmbh.
[105914818]
The customer contacted the siemens customer care center (ccc). A siemens technical application specialist (tas) was at the customer's site for training purposes. Siemens advised the customer to repeat these samples using an alternate method as these results were not reportable. As per the sysmex cs-2500 system instructions for use (ifu), all results were flagged with errors that advise the operator to review the coagulation curve and if required, repeat the test. The customer incorrectly reported the result of approximately 30 seconds. Siemens further investigated the data provided by the customer and determined that the system flagged the results as intended. Siemens determined that the heparin and propofol medications, which the patient was taking at the time of the testing, potentially influenced the activated partial thromboplastin time (aptt) result. Siemens determined that propofol also potentially contributed to the turbid appearance of the affected samples. The customer performed a use error by reporting the flagged result. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[105914820]
Flagged, non-numerical activated partial thromboplastin time (aptt) results were obtained on four samples from the same patient using the dade actin fsl activated ptt reagent on two sysmex cs-2500 systems. Three samples were rerun on the same instruments, resulting in other flagged, non-numerical aptt results. The customer did not provide the data for the third sample and stated that an aptt result of approximately 30 seconds was reported to the physician(s). A sample from this patient was sent to alternate laboratory and run using a sysmex ca-7000 system, resulting in an aptt result of "no coagulation". A corrected report was not provided to the physician(s). It was alleged that the patient's heparin administration was delayed due to the discordant result reported on the patient sample. There are no known reports of adverse health consequences due to the discordant aptt result reported on the patient sample.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00042 |
| MDR Report Key | 7430140 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-13 |
| Date of Report | 2018-05-08 |
| Date of Event | 2018-03-16 |
| Date Mfgr Received | 2018-04-12 |
| Date Added to Maude | 2018-04-13 |
| 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 | CHRISTINA LAM |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243504 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH |
| Manufacturer Street | EMIL-VON-BEHRING-STR. 76 |
| Manufacturer City | MARBURG, 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 | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Generic Name | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Product Code | GGW |
| Date Received | 2018-04-13 |
| Model Number | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Catalog Number | 10445714 |
| Lot Number | 556916 |
| Device Expiration Date | 2019-03-28 |
| 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 PRODUCT GMBH |
| Manufacturer Address | EMIL-VON-BEHRING-STR. 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-13 |