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 DATE(R) ACTIN(R) ACTIVATED CEPHALOPLASTIN REAGENT B4218-1 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[37986215]
Siemens healthcare diagnostics has confirmed internally that for a group of affected action lots including lot 557136, the recovery of controls can be found outside the assigned ranges. Furthermore, a drift in the normal range towards higher results has been observed. This indicates a change of the product performance over the shelf life. Siemens has confirmed a drift greater than 3 seconds in the normal aptt range and / or greater than 15 % in the pathological range over the shelf-life. It is possible that patients with values close to the medical decision points could exhibit a deviation of up to 4 seconds for the normal range and up to 33% for the pathological range. The described drift towards higher aptt values will be recognized in most cases by control recovery out of the assigned range. No u. S. Customers received the affected product. A customer letter (b)(4) was distributed to outside the us customers only. It advised customers who had ordered the affected lots to discontinue the use of the lots. Siemens offered a no charge replacement with a non-impacted lot. .
Patient Sequence No: 1, Text Type: N, H10
[37986216]
The customer experienced biased high qc recoveries for activated partial prothrombin time (aptt) without of range recovery for actin lot 557136 with ci-trol 1 lot 528157b and ci-trol 2 lot 548244a. They also complained of vial to vial variability for this actin lot. It is unknown if patient results were reported to physicians while the lot was in use. It is unknown if patient treatment or diagnosis was altered on the basis of the biased high aptt qc results. There was no report of adverse health consequences as a result of the biased high aptt qc results..
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2016-00011 |
| MDR Report Key | 5430000 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-02-11 |
| Date of Report | 2015-07-28 |
| Date of Event | 2015-04-20 |
| Date Mfgr Received | 2015-07-28 |
| Device Manufacturer Date | 2015-08-21 |
| 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 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 9610806-03-24-2015-002-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DATE(R) ACTIN(R) ACTIVATED CEPHALOPLASTIN REAGENT |
| Generic Name | DATE(R) ACTIN(R) ACTIVATED CEPHALOPLASTIN REAGENT, |
| Product Code | GFO |
| Date Received | 2016-02-11 |
| Catalog Number | B4218-1 |
| Lot Number | 557136 |
| Device Expiration Date | 2015-12-12 |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 76 EMIL VON BEHRING STRASSE MARBURG, 35041 GM 35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-11 |