MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-04-29 for DADE ACTIN FSL ACTIVATED PTT REAGENT B4219-2 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[21719176]
Discrepant elevated activated partial thromboplastin time (aptt) results were obtained on qc and patient samples. Patient results were reported to the physician during an interval of incorrect aptt protocol settings. The qc samples were repeated with the correct protocol settings and lower, within range results were obtained. It is unknown if patient treatment was altered or prescribed due to discrepant aptt results reported. There is no report of adverse outcome to the patients as a result of the discrepant aptt results.
Patient Sequence No: 1, Text Type: D, B5
[22007712]
The cause of the discrepant elevated activated partial thromoboplastin time results is user error. The account entered the incorrect u. S. Settings calibration curve input for the activated partial thromboplastin time (aptt) with actin fsl using lot 547378. These values are manually input by the operator. The incorrect curve has been in use since mid-february. The issue was resolved by directing the account to use a u. S. Settings calibration curve with the appropriate input for the aptt with actin fsl. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2014-00018 |
| MDR Report Key | 3777273 |
| Report Source | 05,06 |
| Date Received | 2014-04-29 |
| Date of Report | 2014-04-01 |
| Date of Event | 2014-03-17 |
| Date Mfgr Received | 2014-04-01 |
| Device Manufacturer Date | 2013-05-08 |
| Date Added to Maude | 2014-06-19 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 FSL ACTIVATED PTT REAGENT |
| Generic Name | DADE ACTIN FSL ACTIVATED PTT REAGENT |
| Product Code | GGW |
| Date Received | 2014-04-29 |
| Catalog Number | B4219-2 |
| Lot Number | 547378 |
| Device Expiration Date | 2015-04-01 |
| 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 | 2014-04-29 |