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 2017-02-21 for DADE ACTIN FS ACTIVATED PTT REAGENT B4218-100 SMN 10445710 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[67877934]
The cause of the discordant elevated aptt result is a use error. An incorrect test protocol was in place in the software for the actin fs aptt reagent since installation in 2015. A siemens healthcare diagnostics technical assistance specialist (tas) incorrectly entered the actin fsl test protocol at the account when the actin fs reagent was installed on the ca-660 instrument on (b)(6) 2015. The incorrect settings were in use for actin fs lots 538492 and 538503. The error was discovered when the account requested the tas to assist them in switching from the actin fs reagent to actin fsl reagent in (b)(6) 2017. The account stated that they have been participating in the siemens healthcare quality assurance program. Quality control values have been recovering in the peer ranges. They also stated that there have been no proficiency survey failures during the period of incorrect settings. The account is a free standing emergency department and stated that their physicians do not use the actin fs reagent aptt for heparin monitoring. The account stated that their physicians have not questioned results during the period. The tas entered correct assay settings for actin fsl to complete the switch to the alternate aptt reagent in (b)(6) 2017. The account is now using the actin fsl reagent with the correct protocol for aptt with actin fsl on the ca-660 system. No further issues have been reported. The issue is resolved. The device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[67877935]
Discordant activated ptt (aptt) results were obtained on qc and patient samples run with the actin fs reagent on the ca-660 instrument. Results were reported to the physicians over a period of time since assay installation in which incorrect reagent settings had been in use. In studies conducted after the use of incorrect settings was discovered, data showed higher or lower results may have been obtained. No corrected results were issued. There is no indication that patient treatment was altered or prescribed on the basis of the discordant aptt results. There is no indication of adverse health consequences to the patient on the basis of the discordant aptt results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00024 |
| MDR Report Key | 6346474 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-21 |
| Date of Report | 2017-02-21 |
| Date of Event | 2015-12-01 |
| Date Mfgr Received | 2017-01-23 |
| Device Manufacturer Date | 2015-05-08 |
| Date Added to Maude | 2017-02-21 |
| 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 |
| Reporter Occupation | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL VON BEHRING STRASSE 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 | 2017-02-21 |
| Catalog Number | B4218-100 SMN 10445710 |
| Lot Number | 538503 |
| Device Expiration Date | 2017-04-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Address | EMIL VON BEHRING STRASSE 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-21 |