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 2018-04-10 for DADE ACTIN FSL ACTIVATED PTT REAGENT 10445714 manufactured by Siemens Healthcare Diagnostics Product Gmbh.
[105518611]
The customer contacted siemens customer care center (ccc) and reported that an operator misinterpreted the "no coagulation" error as the "flat curve" error and incorrectly reported a flagged activated partial thromboplastin time (aptt) result of <20 seconds. Siemens investigated the issue and determined that quality controls were within expected ranges at the time of the event and correct results were produced by the sysmex cs-2500 systems. Based on the sysmex cs-2500 evaluation and algorithm bulletin, "no coagulation" error is triggered when the system is unable to detect a coagulation reaction or a weak clot was formed. The user should: "check the sample for possible anticoagulant contamination, hemolysis, lipemia, etc; verify delivery of sample and reagent; reanalyze the sample with an extended measurement time (within the range of 100 to 1800 seconds) or set "measurement time (sub)" in the test protocol; if reanalysis with extended time gives "no coagulation" message again, the sample is below the detection limits of the detector. Make a comprehensive judgment, taking sample and reagent, etc. Into consideration. If the result is plausible it may be reported as "greater than" per the established laboratory policy. If additional verification is indicated, use your laboratory policy. If additional verification is indicated, use your laboratory's policy to confirm the data. " siemens determined that the customer did not follow the instructions in the sysmex cs-2500 evaluation and algorithm bulletin. The cause of the discordant aptt result reported on a patient sample is a use error. The reagent and systems are performing according to specifications. No further evaluation of these devices is required.
Patient Sequence No: 1, Text Type: N, H10
[105518612]
Non-numerical activated partial thromboplastin time (aptt) results (flagged with "no coagulation") were obtained on three samples from the same patient using the dade actin fsl activated ptt reagent on two sysmex cs-2500 systems. The lab protocol allows the operator to report results flagged with "no coagulation" as greater than the reporting limit as long as the operator reviews the curve and reference the time at 50% as the reportable result. The final result was reported to the physician(s) as <20 seconds and based on this result, the physician(s) restarted the patient's heparin drip at 2 am on (b)(6) 2018. The lab supervisor was made aware of the situation and notified the physician(s), who stopped the patient's heparin drip at 6 am on (b)(6) 2018. On the same day, the patient's blood was redrawn twice and run using the same reagent. The result obtained on the second redrawn sample was reported to the physician(s). There are no known reports of adverse health consequences due to the flagged aptt result reported on the patient sample.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00041 |
| MDR Report Key | 7415170 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-10 |
| Date of Report | 2018-05-16 |
| Date of Event | 2018-03-15 |
| Date Mfgr Received | 2018-04-20 |
| Date Added to Maude | 2018-04-10 |
| 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 | 2018-04-10 |
| 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 | 2018-04-10 |