MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-08-19 for DADE PATHROMTIN SL OQGS manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[4847191]
Falsely elevated activated partial thromboplastin time (aptt) results were obtained on multiple patient's samples run with the dade pathromtin sl reagent. The patient results were reported to the physician who questioned the results. The patient samples were repeated when qc was found to be out of range high. Patient results were repeated and lower results were obtained. It is unknown if patient treatment was altered on the basis of the falsely elevated aptt results. There is no report of adverse outcome to patients as a result of the falsely elevated aptt results.
Patient Sequence No: 1, Text Type: D, B5
[12342585]
The cause of the discrepant falsely elevated aptt results is unknown. Qc at 5:41 was out of range, indicating a potential issue with the reagent vial that had been on board of the instrument for greater than 40hr. Based on internal testing and the complaint investigation, siemens has no evidence for a systematic malfunction of the affected lot. The issue seems correlated with an unknown cause of reduced reagent stability of a single reagent vial while being on board. The issue seems to be a single case at the customer site. Vials tested internally for reagent stability did not shown any deviation from the specifications, and we have no further complaint on the same issue of the affected lot. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2014-00020 |
| MDR Report Key | 4019407 |
| Report Source | 01,05,06 |
| Date Received | 2014-08-19 |
| Date of Report | 2014-07-22 |
| Date of Event | 2014-07-21 |
| Date Mfgr Received | 2014-07-22 |
| Device Manufacturer Date | 2013-09-06 |
| Date Added to Maude | 2014-09-03 |
| 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 | EMIL VON BEHRING STRASSE 76 |
| Manufacturer City | MARBURG, D-35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DADE PATHROMTIN SL |
| Generic Name | DADE PATHROMTIN SL |
| Product Code | GFO |
| Date Received | 2014-08-19 |
| Catalog Number | OQGS |
| Lot Number | 536664 |
| Device Expiration Date | 2015-04-14 |
| 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 | 2014-08-19 |