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 2017-03-28 for INNOVANCE D-DIMER OPBP035 SMN 10445979 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[70999976]
The customer contacted the siemens customer care center concerning a discordant low d-dimer patient result obtained on the cs-2100i system. The issue was detected with a level 2 qc shift low on two cs2100i instruments at three days post reconstitution of the reagent. Siemens healthcare diagnostics headquarters support center evaluated the instrument data. The instability is attributed to water quality at the account. The device is operating within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[70999977]
A discordant depressed innovance d-dimer result was obtained on a patient sample on the sysmex cs-2100i instrument system. The result was reported to the physician. It is unknown if the result was questioned. The same sample was later repeated on the alternate cs-2100i system and a higher result was obtained. A corrected result was issued. There is no indication that patient treatment was altered or prescribed on the basis of the discordant depressed d-dimer result. There was no report of adverse health consequences as a result of the discordant depressed d-dimer result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00041 |
| MDR Report Key | 6438681 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-28 |
| Date of Report | 2017-03-28 |
| Date of Event | 2017-02-28 |
| Date Mfgr Received | 2017-03-07 |
| Device Manufacturer Date | 2016-05-09 |
| Date Added to Maude | 2017-03-28 |
| 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 | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE 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 | 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 | INNOVANCE D-DIMER |
| Generic Name | INNOVANCE D-DIMER |
| Product Code | DAP |
| Date Received | 2017-03-28 |
| Catalog Number | OPBP035 SMN 10445979 |
| Lot Number | 46090 |
| Device Expiration Date | 2018-02-07 |
| 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 STRASSE 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-28 |