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 2016-02-11 for DADE ACTIN FS ACTIVATED PTT REAGENT B4218 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[38032784]
Siemens healthcare diagnostics has confirmed complaints about downward drifting recovery of control plasma p lots 509973a and 509973c with lots 538484 and 538485a of dade? Actin? Fs activated ptt reagent on the bcs/bcs xp system. The impact on patient sample recovery with the dade actin fs activated ptt reagent lots was investigated. The investigation showed no effect on patient sample recovery. No lookback for previously reported patient test results was recommended. No us customers received the affected product. A customer letter was distributed to outside us customers. The outside us customer letter (b)(4) dated june 2015 was issued to the potentially impacted customers. The communication was sent to inform those customers using the combination of actin fs and control plasma p on the bcs/bcs xp system about the issue and to recommend usage of an alternate control plasma p lot of dade ci-trol 2/citrol 3 as pathological control instead of control plasma p.
Patient Sequence No: 1, Text Type: N, H10
[38032845]
A customer complained of downward drift of control plasma p (cpp) control recoveries with actin fs activated ptt reagent on the bcs system. Patient samples were run during the period of control recovery drift. The complainant gave no indication of patient sample results being questioned by physicians during the period of control recovery drift. There is no indication of patient treatment being altered or prescribed during the period of control recovery drift. There was no report of adverse health consequences during the period of control recovery drift.
Patient Sequence No: 1, Text Type: D, B5
[38254490]
Siemens healthcare diagnostics inc. Filed the initial mdr (9610806-2016-00006) on february 11, 2016. February 12, 2016 additional information: no us customers received the affected product. A customer letter was distributed to outside us customers. The outside us customer letter br-02315 dated march 2015 was issued to the potentially impacted customers. The communication was sent to inform those customers using the combination of actin fs and control plasma p on the bcs/bcs xp system about the issue and to recommend usage of an alternate control plasma p lot of dade ci-trol 2/ci-trol 3 as pathological control instead of control plasma p.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2016-00006 |
| MDR Report Key | 5430895 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-02-11 |
| Date of Report | 2015-06-16 |
| Date of Event | 2015-03-30 |
| Date Mfgr Received | 2015-03-19 |
| Device Manufacturer Date | 2014-06-04 |
| Date Added to Maude | 2016-02-11 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 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 | 76 EMIL VON BEHRING STRASSE |
| 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 | 2016-02-11 |
| Catalog Number | B4218 |
| Lot Number | 538484 |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 76 EMIL VON BEHRING STRASSE MARBURG, 35041 GM 35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-11 |