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 2017-08-18 for DADE ACTIN FSL ACTIVATED PTT REAGENT 10445714 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[83686235]
Siemens healthcare diagnostics inc. (siemens) analysed the data provided by the customer to determine the cause of the different aptt results obtained across different systems for samples from this patient. Siemens determined that the kinetic reactions from the data printout are consistent with the patient samples on argatroban therapy. The internal quality controls on the bcs xp system and sysmex ca-7000 system recovered within expected range at the time of the event and there is no indication that other patients were impacted. The affected patient is on argatroban, a direct thrombin inhibitor (dti), which influences aptt results for all manufacturers' reagents and systems. Reagent sensitivity can vary across different systems. A direct comparison of the aptt results is not possible. Siemens determined that the customer reported non-reportable, flagged results from the sysmex ca-7000 system. Based on the sysmex "ca series checking methods and evaluation guide", ere 1 (early reaction error: slow reaction) occurs when the slope of the coagulation curve around the detection point is too low. This error may be reportable after visual review of the measurement curve to ensure the aptt value determined at the 50% is consistent with the kinetics reaction. Ato (analysis time over) detects whether the reaction end point is correct. If the sample reaction end angle is greater than the permitted angle at the maximum detection time, the result will be flagged with an analysis time over error. If this error persists, and alternate protocol should be followed. Siemens determined that the reaction curves from the sysmex ca-7000 system demonstrate increasing angle in the plateau area of the curve, however clotting was observed earlier on the reaction curve. Based on the sysmex bulletin and guides, operators can report results with the ere1 flag but cannot report results with the ato flag. The customer has implemented their own policy to accept ato errors when clear clotting is demonstrated. Siemens offered to provide flag interpretation and results evaluation bulletins for the sysmex ca-7000 system and the bcs xp system to the customer and the customer rejected the offer. The customer stated that the lab has these bulletins but will not change their lab policy-even if their policy conflicts with siemens guidelines. The cause of the event is user error as the customer reported non-reportable, flagged results. The instruments and reagent are performing according to specifications. No further evaluation of this device is required. Mdr 9610806-2017-00092 was filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[83686236]
A flagged high activated partial thromboplastin time (aptt) result was obtained on a patient sample on the sysmex ca-7000 system. This result was not reported to the physician. The same patient sample was rerun on an alternate bcs xp system, resulting within the therapeutic range for patients on argatroban. The lab considered this result to be the correct aptt result for this patient. The patient blood was redrawn and run on the initial system in duplicate, resulting higher than the therapeutic range for patients on argatroban (40 - 80 seconds). The medical staff adjusted the patient's argatroban treatment based on the reported aptt results to maintain the patient's aptt result within the therapeutic range. The medical staff monitors the patient's aptt result and sends a sample from the patient to the lab every 3 hours, while the patient is on extracorporeal membrane oxygenation (ecmo). The correct aptt result for this patient is unknown. There are no known reports of adverse health consequences due to the customer reporting flagged aptt results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00091 |
| MDR Report Key | 6804938 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-18 |
| Date of Report | 2017-08-18 |
| Date of Event | 2017-07-23 |
| Date Mfgr Received | 2017-07-24 |
| Date Added to Maude | 2017-08-18 |
| 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 | 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 | 2017-08-18 |
| Model Number | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Catalog Number | 10445714 |
| Lot Number | 547484 |
| Device Expiration Date | 2018-03-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-08-18 |