MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-07-30 for DADE ACTIN FSL ACTIVATED PTT REAGENT B4219-2 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[4609104]
Depressed activated partial thromboplastin time (aptt) results well below laboratory reference ranges were obtained on patient samples. Patient results were reported to the physician who questioned the results as discordant low. The account notes that there was a delay in patient surgery due to the repeat testing of the depressed aptt results for one patient. It is unknown if patient treatment was otherwise altered or prescribed due to questioned, depressed aptt results. There is no report of adverse outcome to the patients as a result of the questioned, depressed aptt results.
Patient Sequence No: 1, Text Type: D, B5
[12150518]
The cause of the discrepant depressed activated partial thromboplastin time results is unknown. Siemens healthcare diagnostics has neither an indication for a malfunction of the analyzer nor for a performance issue of the reagent being used. The instrument is performing within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2014-00021 |
| MDR Report Key | 3965825 |
| Report Source | 05,06 |
| Date Received | 2014-07-30 |
| Date of Report | 2014-06-30 |
| Date of Event | 2014-06-29 |
| Date Mfgr Received | 2014-06-30 |
| Device Manufacturer Date | 2013-05-08 |
| Date Added to Maude | 2014-08-06 |
| 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 | AYDEE CRAWFORD |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026316312 |
| 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 | 2014-07-30 |
| Catalog Number | B4219-2 |
| Lot Number | 547389 |
| Device Expiration Date | 2015-10-09 |
| 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 | 2014-07-30 |