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 2018-01-30 for DADE ACTIN FS ACTIVATED PTT REAGENT 10445710 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[98645907]
Siemens healthcare diagnostics inc. Has investigated the provided information to determine the cause of the falsely high activated partial thromboplastin time (aptt) patient results on multiple patients generated on a sysmex cs-5100 analyzer after quality control (qc) failure. No product non-conformance nor system issue could be identified. The instrument performed as expected. A high deviation of quality control was clearly displayed to the user. The deviation is visible for the affected (2) two days in the qc chart. The instrument and the qc protocol detected and displayed the issue. The customer did not adequately react to the qc error information in the pop-up window of the instrument screen. The instrument and reagent are performing according to specifications. No further evaluation of this device is required. Mdr 9610806-2018-00017 was filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[98645908]
Falsely high, flagged activated partial thromboplastin time (aptt) patient results on multiple patients were generated on a sysmex cs-5100 analyzer after quality control (qc) failure. These results were reported to the physician(s). The same patient samples were repeated on a different sysmex cs-5100 (with acceptable qc) and lower aptt patient results were generated. It is unknown if the repeat results were reported out to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant high, flagged patient results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00018 |
| MDR Report Key | 7228075 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-30 |
| Date of Report | 2018-01-30 |
| Date of Event | 2018-01-05 |
| Date Mfgr Received | 2018-01-05 |
| Device Manufacturer Date | 2017-07-07 |
| Date Added to Maude | 2018-01-30 |
| 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 PTT REAGENT |
| Generic Name | DADE ACTIN FS ACTIVATED PTT REAGENT |
| Product Code | GGW |
| Date Received | 2018-01-30 |
| Catalog Number | 10445710 |
| Lot Number | 538530 |
| Device Expiration Date | 2019-05-30 |
| 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 | 2018-01-30 |