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 2018-01-05 for DADE ACTIN FSL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT 10445714 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[97592509]
Siemens healthcare diagnostics has investigated the provided information to determine the cause of the discordant, high activated partial thromboplastin time (aptt) patient result generated on the sysmex ca-660 analyzer. Siemens requested the customer to perform a precision study and no product non-conformance nor system issue could be identified. A possible potential cause of the event may be related to sample handling or the nature of the sample. The cause of the discordant high aptt result on the sysmex ca-660 analyzer is unknown. The instrument and reagent are performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[97592510]
A discordant high activated partial thromboplastin time (aptt) patient result of 184. 1sec was generated on a sysmex ca-660 analyzer. This result was not reported. The same sample was repeated on the same system (sysmex ca-660 analyzer) and an aptt patient result of 109sec (repeat result 1) was generated. This result was not reported. The same sample was repeated on a sysmex ca-560 analyzer and an aptt patient result of 103sec (repeat result 2) was generated and reported to the physician. All results were run on the same day ((b)(6) 2017) on the same patient sample. There are no reports of patient intervention or adverse health consequence due to the discordant high aptt patient result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00004 |
| MDR Report Key | 7168807 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-05 |
| Date of Report | 2018-01-05 |
| Date of Event | 2017-12-12 |
| Date Mfgr Received | 2017-12-12 |
| Device Manufacturer Date | 2016-06-20 |
| Date Added to Maude | 2018-01-05 |
| 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 FSL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT |
| Generic Name | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Product Code | GGW |
| Date Received | 2018-01-05 |
| Catalog Number | 10445714 |
| Lot Number | 547494A |
| Device Expiration Date | 2018-05-17 |
| 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, 35041 GM 35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-05 |