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 2017-06-16 for INNOVANCE D-DIMER INNOVANCE D-DIMER KIT 10445979 (SEE SECTION H10) manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[77870281]
Siemens healthcare diagnostics inc. (siemens) application specialist analyzed the sysmex cs-2100i backup files to determine the cause of the discordant d-dimer (ddi) results. Siemens performed a linearity test with the affected patient sample and the sample did not show linearity. This is a sample specific issue. The instrument and the reagents are performing according to specifications. No further evaluation of this device or reagent is required. The innovance d-dimer reagent described is not marketed in the us and the pma/510(k) number in section g5 is for the us specific kits. The reagents marketed in the us have (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[77870282]
Discordant d-dimer results were obtained on 2 samples from the same patient on the sysmex cs-2100i system using the innovance d-dimer kit. The operator ran a patient sample for d-dimer (ddi) on the sysmex cs-2100i system and obtained a flagged ddi result 7. 12 mg/l. The result was flagged with hemolytic sample and lipemic sample. This result was reported to the physician. The operator re-ran the same patient sample on the same sysmex cs-2100i system and obtained a ddi result of 7. 39 mg/l. The result was flagged with error messages: hemolytic sample, lipemic sample, and defective sample volume. The instrument automatically diluted the same patient sample by 1/8 and a non-numerical (---. --) flagged result was obtained. The 1/8 diluted patient sample was flagged with error messages: hemolytic sample, lipemic sample, defective sample volume, dilution ratio was changed, and extrapolation boundary over (lower). The "extrapolation boundary over (lower)" flag indicates a result below clinical cut-off (i. E. <0. 19 mg/l). The operator manually diluted the same patient sample by? And re-ran the sample on the same sysmex cs-2100i system. A ddi result of 1. 96 mg/l was obtained. The patient blood was re-drawn to eliminate any pre-analytical issue with the original specimen and re-run on the same sysmex cs-2100i system. A flagged ddi result of 10. 45 mg/l was obtained for this re-drawn patient sample. The result was flagged with error messages: hemolytic sample, lipemic sample, and defective sample volume. The instrument automatically diluted the same re-drawn patient sample by 1/8 and a non-numerical (---. --) flagged ddi result was obtained. The 1/8 diluted patient sample was flagged with error messages: hemolytic sample, lipemic sample, defective sample volume, dilution ratio was changed, and extrapolation boundary over (lower). The operator stated that the specimens were correctly filled and the volume flags are only seen because the operator re-ran the specimen multiple times. Both, original and re-drawn, samples have hemolytic flags but the operator stated that both samples did not appear hemolytic nor lipemic. Only the initial ddi result of 7. 39 mg/l was reported to the physician. The correct result is unknown. There are no known reports of patient intervention or adverse health consequences due to the discordant d-dimer results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00063 |
| MDR Report Key | 6647462 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-16 |
| Date of Report | 2017-06-16 |
| Date of Event | 2017-05-25 |
| Date Mfgr Received | 2017-05-25 |
| Date Added to Maude | 2017-06-16 |
| 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 | 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 | 2017-06-16 |
| Model Number | INNOVANCE D-DIMER KIT |
| Catalog Number | 10445979 (SEE SECTION H10) |
| Lot Number | 46914 |
| Device Expiration Date | 2018-10-23 |
| Operator | HEALTH PROFESSIONAL |
| 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 | EMIL-VON-BEHRING- STR. 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-16 |