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 2017-12-21 for DADE ACTIN FSL ACTIVATED PTT REAGENT 10445714 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[96123109]
A siemens healthcare diagnostics (siemens) technical solution center (tsc) technician contacted the operator to determine the cause of the discordant activated partial thromboplastin time (aptt) results obtained on the patient sample on the sysmex cs-2500 system and sysmex ca-660 system. The lab suspected that the sample was incorrectly collected, which resulted in heparin contamination from the iv line. Unfractionated heparin will potentially depreciate in sample tubes over time. Siemens cannot determine if the sample tube was properly collected or handled properly post phlebotomy and pre-analytical issues potentially contributed to the discordant results obtained on this patient sample. Siemens tsc specialist educated the lab on how to handle sample error codes and preanalytical issues and emailed the sysmex cs-2500 system evaluation and check algorithm (for us only) bulletin to the operator. Based on the bulletin, the "analysis time over check is able to detect whether the reaction end point is correct. If the sample reaction end angle is greater than the permitted angle at the maximum reading time, the result will be flagged with an "analysis time over" error. The situation occurs when testing samples with prolonged clotting times. " based on the same bulletin, "sharp drop check is able to detect a sudden drop of a/d value. After the start of the clotting assay, if the dh drops over 32 levels, the result will be flagged with a "coagulation curve error" error. " the cause of the event is unknown. The systems and reagent are performing according to specifications. No further evaluation of this system or reagent is required.
Patient Sequence No: 1, Text Type: N, H10
[96123110]
A patient sample was tested for activated partial thromboplastin time (aptt) on (b)(6) 2017 and an aptt result of 37. 0 seconds was reported to the physician(s). The patient was admitted into the hospital and was administered intravenous (iv) heparin. On the morning of (b)(6) 2017, the patient's blood was redrawn and run on the sysmex cs-2500 system, resulting in a flagged aptt result of >160 seconds. Due to this flagged result, the operator instructed the nurse to stop the patient's iv heparin treatment for one hour and to redraw the patient's blood. The operator did not officially release this result on the patient's chart. In the afternoon, the patient's blood was redrawn again and run on the same system. A flagged aptt result was obtained on the patient sample and the system automatically reran the sample, resulting in a discordant, falsely elevated aptt result of 85. 7 seconds. The operator informed the nurse that the lab was investigating the results and advised the nurse to not resume administering iv heparin to the patient. The operator reran the sample on an alternate sysmex ca-660 system, using the same reagent, multiple times and obtained results lower than the result obtained on the sysmex cs-2500 system. The same sample was rerun on the initial system, with and without lid, and results lower than the initial discordant result were obtained. The patient's blood was redrawn, from the arm opposite from the iv, and run on the same system, resulting lower than the previous results. This result was reported to the physician(s) as a correction to the result previously reported on the patient sample (85. 7 seconds). Based on the corrected result, the patient's iv heparin treatment was resumed. The patient's blood was redrawn, every 4 hours, and tested for aptt and two redrawn samples (t23552 and t21483) from the same patient recovered in elevated aptt results. These elevated aptt results were reported to the physician(s). The system used to run these patient samples is unknown. The operator indicated that the patient's aptt results are now consistently recovering at approximately 60 seconds. The customer indicated that none of the samples from this patient were lipemic, icteric, hemolyzed or clotted. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated aptt results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00150 |
| MDR Report Key | 7139758 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-12-21 |
| Date of Report | 2018-01-16 |
| Date of Event | 2017-11-28 |
| Date Mfgr Received | 2017-12-22 |
| Date Added to Maude | 2017-12-21 |
| 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 | 2017-12-21 |
| Model Number | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Catalog Number | 10445714 |
| Lot Number | 556902 |
| Device Expiration Date | 2018-11-10 |
| 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 | 2017-12-21 |