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 2017-08-28 for INNOVANCE D-DIMER 10445980 (SEE SECTION H10) manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[83863205]
The patient sample has been checked for hemolysis, icterus, lipemia and micro-clots and no issues were observed. The customer indicated that they were not able to retest the patient for d-dimer because they were not able to contact the patient to obtain a new sample. The cause of the issue is unknown. The innovance d-dimer reagent with catalog number 10445980 described is not marketed in the united states (us) and the pma/510(k) number is for the us specific reagents. The innovance d-dimer reagents marketed in the us have catalog numbers 10445981 and 10445982.
Patient Sequence No: 1, Text Type: N, H10
[83863206]
A false negative d-dimer result was obtained on a patient sample on the sysmex cs-2100i instrument. The false negative result was reported to the physician, who questioned the result. It is unknown whether any medical procedure or treatment was performed due to the false negative result. The following day, the same patient sample was rerun, in duplicate, on an alternate sysmex cs-2100i instrument and the original instrument. The sample was repeated with a 1:8 dilution on both instruments, resulting higher. It is unknown whether a corrected report was provided to the physician. There are no known reports of patient intervention or adverse health consequences due to the false negative d-dimer result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00093 |
| MDR Report Key | 6823898 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-28 |
| Date of Report | 2017-09-26 |
| Date of Event | 2017-08-01 |
| Date Mfgr Received | 2017-08-07 |
| Date Added to Maude | 2017-08-28 |
| 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 | CHRISTINA LAM |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243504 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL-VON-BEHRING-STR. 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 | INNOVANCE D-DIMER |
| Generic Name | INNOVANCE D-DIMER |
| Product Code | DAP |
| Date Received | 2017-08-28 |
| Model Number | INNOVANCE D-DIMER |
| Catalog Number | 10445980 (SEE SECTION H10) |
| Lot Number | 46678 |
| Device Expiration Date | 2018-08-28 |
| 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 | 2017-08-28 |