MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-02-04 for BERICHROM ANTITHROMBIN III OWWR manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[5351138]
Falsely elevated antithrombin iii results were obtained on two patient samples run on the bcs xp instrument. A patient result was reported to the physician for one of the samples. Both samples were repeated after the thrombin reagent used was replenished. Lower results were obtained and corrected result were reported. It is unknown if patient treatment was altered or prescribed on the basis of the falsely elevated antithrombin iii results. There is no report of adverse outcome to the patient as a result of the falsely elevated antithrombin iii results.
Patient Sequence No: 1, Text Type: D, B5
[12944141]
The cause of the falsely elevated antithrombin iii (atiii) results is user error. Siemens customer care center representatives investigation of instrument data has determined the sequence of events leading to the discrepant elevated results. The customer indicated in the complaint that they had run out of the thrombin reagent used in the atiii test after the initial processing of the samples. Review of the instrument files indicated insufficient reagent errors were present prior to sample processing. There is no indication of instrument malfunction. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2015-00002 |
| MDR Report Key | 4484141 |
| Report Source | 05,06 |
| Date Received | 2015-02-04 |
| Date of Report | 2015-01-08 |
| Date of Event | 2015-01-08 |
| Date Mfgr Received | 2015-01-08 |
| Device Manufacturer Date | 2014-04-14 |
| Date Added to Maude | 2015-03-09 |
| 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 | BERICHROM ANTITHROMBIN III |
| Generic Name | BERICHROM ANTITHROMBIN III |
| Product Code | JPE |
| Date Received | 2015-02-04 |
| Catalog Number | OWWR |
| Lot Number | 520286 |
| Device Expiration Date | 2016-01-29 |
| 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 | 2015-02-04 |