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 2018-01-19 for DADE ACTIN FS ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT 10445710 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[98055432]
Siemens healthcare diagnostics inc. Is investigating the cause of the discordant high activated partial thromboplastin time (aptt), prothrombin time (pt), international normalized ratio (inr), and derived fibrinogen (der fib) patient results on one (1) patient sample that were generated on a sysmex cs-5100 analyzer (sn (b)(4)). Mdr 9610806-2018-00014 was filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[98055433]
Discordant high activated partial thromboplastin time (aptt), prothrombin time (pt), international normalized ratio (inr), and derived fibrinogen (der fib) patient results on one (1) patient sample were generated on a sysmex cs-5100 analyzer (sn (b)(4)). These results were not reported to the physician as they did not meet the clinical history of the patient. The same patient sample was repeated on a different sysmex cs-5100 (sn (b)(4)) and lower aptt, pt, inr, and der fib patient results were generated. These results were reported to the physician. All results were run on the same day ((b)(6) 2017) on the same patient sample. The pt /inr /der fib patient results (initial and repeat) were generated using thromborel s reagent and aptt patient results (initial and repeat) were generated using the dade actin fs activated partial thromboplastin time (ptt) reagent. There are no reports of patient intervention or adverse health consequences due to the discordant high aptt, pt, inr, and der fib patient results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00013 |
| MDR Report Key | 7207695 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-19 |
| Date of Report | 2018-01-29 |
| Date of Event | 2017-12-26 |
| Date Mfgr Received | 2018-01-24 |
| Device Manufacturer Date | 2017-03-17 |
| Date Added to Maude | 2018-01-19 |
| 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 | LORIANN RUSSO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242287 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL VON BEHRING STRASSE 76 |
| Manufacturer City | MARBURG, 35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DADE ACTIN FS ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT |
| Generic Name | DADE ACTIN FS ACTIVATED PTT REAGENT |
| Product Code | GGW |
| Date Received | 2018-01-19 |
| Catalog Number | 10445710 |
| Lot Number | 538525 |
| Device Expiration Date | 2019-02-21 |
| 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 STRASSE 76 MARBURG, 35041 GM 35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-19 |