MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-10-02 for DADE ACTIN FSL ACTIVATED PTT REAGENT B4219 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[2971334]
A falsely depressed activated partial thromboplastin time (aptt) clotting time result was auto-verified on the bcs(r) xp system and reported on a patient sample. The test coagulation curve was subsequently reviewed manually within the laboratory. The laboratory called the floor to retract the autoverified result as falsely depressed. The patient had expired in the interval between the autoverification and the call to the floor to retract the result. Patient treatment was not altered or prescribed on the basis of the falsely depressed aptt.
Patient Sequence No: 1, Text Type: D, B5
[10141527]
The cause of the falsely depressed aptt result is unknown. The account states that qc and other patients before and after the samples on this individual patient were acceptable. These questionable results were patient specific. Siemens healthcare diagnostics is investigating the incident. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2012-00016 |
| MDR Report Key | 2769101 |
| Report Source | 05,06 |
| Date Received | 2012-10-02 |
| Date of Report | 2012-09-24 |
| Date of Event | 2012-09-24 |
| Date Mfgr Received | 2012-09-24 |
| Date Added to Maude | 2013-01-18 |
| 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 | 2012-10-02 |
| Catalog Number | B4219 |
| Lot Number | 547325 |
| Device Expiration Date | 2011-11-11 |
| 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 | 1. Other | 2012-10-02 |