MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-04-20 for DADE ACTIN FS ACTIVATED PTT REAGENT 10445710 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[73517779]
A siemens healthcare diagnostics inc. Field service engineer (fse) was dispatched to the customer site to determine the cause of the discordant, elevated prothrombin time (pt) and activated partial thromboplastin time (aptt) result on the sysmex cs-5100 system and found that there were no issues with the system before or after processing this patient's sample. Further investigation for this patient sample is not possible because the customer's back up does not contain log and result files from the incident date (03/28/2017). It is possible that the discordant results were due to the fact the customer set "standard sample tube" on all three systems despite using three different types of tubes from becton dickinson. The instrument is performing according to specifications. No further evaluation of this device is required. The other assay that provided discordant result in this incident is thromborel s. The details for this assay is listed below: common device name: thromborel s. Model number: thromborel s. Catalog number: 10446445. Lot number: 546971. Expiration date (mm/dd/yyyy): 09/12/2018. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[73517780]
A discordant, falsely elevated activated partial thromboplastin time (aptt) and a discordant, falsely high prothrombin time (pt) result were obtained on a patient's sample on the sysmex cs-5100 instrument. These results were not provided to the physician. The same patient's blood sample was re-run on another sysmex cs-5100 system. The results obtained from the repeat testing aligned within the patient's medical history. The re-run results were reported to the physician. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated aptt and pt results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00051 |
| MDR Report Key | 6508230 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-20 |
| Date of Report | 2017-04-20 |
| Date of Event | 2017-03-28 |
| Date Mfgr Received | 2017-03-29 |
| Date Added to Maude | 2017-04-20 |
| 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 | ELIZABETH BERNASCONI |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9146216083 |
| 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 FS ACTIVATED PTT REAGENT |
| Generic Name | DADE ACTIN FS ACTIVATED PTT REAGENT |
| Product Code | GGW |
| Date Received | 2017-04-20 |
| Model Number | DADE ACTIN FS ACTIVATED PTT REAGENT |
| Catalog Number | 10445710 |
| Lot Number | 538521A |
| Device Expiration Date | 2018-11-22 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-20 |