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 2017-08-11 for DADE ACTIN FSL ACTIVATED PTT REAGENT 10445714 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[82792170]
Siemens healthcare diagnostics inc. (siemens) headquarters support center (hsc) specialist analyzed information provided by the customer to determine the cause of the discordant falsely elevated activated partial prothrombin time (aptt) on the sysmex ca-1500 coagulation analyzer and the bcs xp system. Siemens determined that the issue is limited to samples from this specific patient. There is no indication of a systemic or reagent issue. The patient was on unfractionated heparin and propofol, a white milky emulsion anesthetic. The patient plasma was lipemic from this medication, potentially causing optical interference with analysis. An alternate sample was processed on a stago analyzer with an alternate non-siemens reagent and an aptt value of 66 seconds was obtained. The aptt assay is reported in raw seconds and is not a calibrated assay. Reagent sensitivity can vary drastically between reagent products across different manufacturers. Direct comparison of the raw aptt result of 40 seconds obtained on the bcs xp system and the aptt result of 66 seconds determined on the stago system is not possible. The results from each system must be evaluated against a system specific normal reference range and heparin therapeutic range. The patient's triglyceride level of 479 mg/dl exceeded the interference limitations of the bcs xp system and the sysmex ca-1500 analyzer. Interfering substances such as triglycerides and propofol in the affected samples is potentially another cause of the discordant results. Both systems appropriately flagged the aptt results for these patient samples. This issue is isolated to this specific sample. The cause of the discordant, falsely elevated aptt results on the sysmex ca-1500 coagulation analyzer and the bcs xp system is unknown. The instrument and reagents are performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[82792191]
Multiple activated partial thromboplastin time (aptt) results were obtained on a lipemic patient sample on the sysmex ca-1500 coagulation analyzer and bcs xp system. A discordant, falsely elevated aptt result of >120 seconds was reported to the physician, who did not question the result. Based on this result, physician stopped the patient's heparin infusion for 60 minutes and decreased the patient's heparin therapy by 200 units per hour. The customer indicated the patient was not negatively impacted by the treatment modification. The patient blood was re-drawn four additional times and three samples were run on both systems. The customer observed differences in the ptt results between the two systems and contacted a siemens technical support specialist, who advised the customer to not report these results outside the lab. The customer did not report out these results and alerted the physician the next day to interpret aptt results with caution. The last redrawn sample was run on an alternate non-siemens (stago) instrument. The customer reported this result to the physician. There are no known reports of adverse health consequences due to the discordant, falsely elevated aptt results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00082 |
| MDR Report Key | 6788559 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-11 |
| Date of Report | 2017-08-11 |
| Date of Event | 2017-07-17 |
| Date Mfgr Received | 2017-07-17 |
| Date Added to Maude | 2017-08-11 |
| 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 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 | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Generic Name | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Product Code | GGW |
| Date Received | 2017-08-11 |
| Model Number | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Catalog Number | 10445714 |
| Lot Number | 547494A |
| Device Expiration Date | 2018-05-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2017-08-11 |