MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-07-14 for INNOVANCE D-DIMER 10445980 (SEE SECTION H10) manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[80076187]
The operator did not provide any clinical presentation, disease or symptom information for this patient and siemens healthcare diagnostics inc. Is not aware of any patient harm caused by the discordant results. It is unknown whether the patient is truly positive or negative. The cause of the discordant d-dimer (ddi) results cannot be determined and is unknown. The operator from the alternate facility, (b)(6), indicated that the stratus cs 200 analyzer d-dimer results were correct and there is no indication the stratus cs 200 analyzer did not perform as intended. There is no supporting patient information that the correct d-dimer result should be positive, as the operator indicated. An individual false positive result on the stratus cs 200 would not be an indication that the assay/analyzer is, in general, not performing as intended since d-dimer assays are typically used as an exclusion marker for dvt (deep vein thrombosis) / pe (pulmonary embolism). For this purpose, the respective assays have a high sensitivity with a remarkably lower specificity. No further evaluation of this device was performed.
Patient Sequence No: 1, Text Type: N, H10
[80076188]
A positive d-dimer (ddi) result was obtained on a patient sample on the stratus cs 200 analyzer at (b)(6). Based on this positive ddi result, the patient was referred to the (b)(6) hospital for an urgent treatment. The patient blood was re-drawn and run at the (b)(6) hospital. A negative ddi result was obtained on the bcs xp system and reported to the physician. The patient was sent home based on the negative ddi result obtained on the bcs xp system. There are no reports of patient intervention or adverse health consequences due to the discordant ddi result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00070 |
| MDR Report Key | 6714892 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-14 |
| Date of Report | 2017-08-25 |
| Date of Event | 2017-03-31 |
| Date Mfgr Received | 2017-07-26 |
| Date Added to Maude | 2017-07-14 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ELIZABETH BERNASCONI |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242495 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL-VON-BEHRING-STR. 76 |
| Manufacturer City | 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 | INNOVANCE D-DIMER |
| Generic Name | INNOVANCE D-DIMER |
| Product Code | DAP |
| Date Received | 2017-07-14 |
| Model Number | INNOVANCE D-DIMER |
| Catalog Number | 10445980 (SEE SECTION H10) |
| Lot Number | 46913 |
| Device Expiration Date | 2018-10-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Address | EMIL-VON-BEHRING-STR. 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-14 |