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 2017-02-10 for DADE ACTIN FSL B4219-2 SMN 10445714 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[67342304]
The cause of the discordant elevated aptt result is unknown. The information provided was evaluated. The customer stated that quality control was within laboratory ranges and there have been no issues with other patient samples. Siemens headquarters support center is investigating the incident.
Patient Sequence No: 1, Text Type: N, H10
[67342305]
A discordant elevated activated ptt (aptt) result was obtained on a patient sample run with the actin fsl reagent on the ca-1500 instrument. The result was reported to the physician who questioned the result. The same sample was re-run on the same instrument and a lower results was obtained. A lower result was also obtained on a redraw sample and a corrected report was issued. There is no indication that patient treatment was altered or prescribed on the basis of the discordant elevated aptt result. There is no indication of adverse health consequences to the patient on the basis of the discordant elevated aptt result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00021 |
| MDR Report Key | 6321595 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-10 |
| Date of Report | 2017-02-10 |
| Date of Event | 2017-01-08 |
| Date Mfgr Received | 2017-01-12 |
| Device Manufacturer Date | 2016-04-29 |
| Date Added to Maude | 2017-02-10 |
| 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 | 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 FSL |
| Generic Name | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Product Code | GGW |
| Date Received | 2017-02-10 |
| Catalog Number | B4219-2 SMN 10445714 |
| Lot Number | 547492 |
| Device Expiration Date | 2018-04-05 |
| 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 STRASSE 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-10 |