MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-07-23 for DIMENSION? DF207 SMN 10700795 manufactured by Siemens Healthcare Diagnostics Inc..
[114694151]
Mdrs 2517506-2018-00422, 2517506-2018-00423, 2517506-2018-00425, 2517506-2018-00426, were filed for the same event. The customer contacted siemens customer care center (ccc) and reported a discordant, falsely elevated tacrolimus (tac) patient result was obtained on the dimension exl system. Siemens is investigating the event.
Patient Sequence No: 1, Text Type: N, H10
[114694152]
A discordant falsely elevated tacrolimus (tac) result was obtained on a patient sample on a dimension exl instrument. The same sample was processed on an alternate methodology and a lower result was obtained. A new sample for the same patient was processed on the same date using an alternate dimension instrument and high result was obtained consistent with the initial result. The result obtained on the alternate instrument was questioned by the laboratory since the patient sample processed on an earlier date obtained a lower result. This prior sample was then processed on the alternate dimension instrument and on the original dimension instrument which both confirmed the initial high result. Patient treatment was delayed due to the high result. There was no known impact on patient treatment or care and no alleged patient harm due to the discordant elevated tac result or due to the delay in treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00424 |
| MDR Report Key | 7710164 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-23 |
| Date of Report | 2018-11-09 |
| Date of Event | 2018-06-21 |
| Date Mfgr Received | 2018-10-29 |
| Device Manufacturer Date | 2018-04-20 |
| Date Added to Maude | 2018-07-23 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | 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 INC. |
| Manufacturer Street | 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 197146101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION? |
| Generic Name | DIMENSION?TAC TACROLIMUS FLEX? REAGENT CARTRIDGE |
| Product Code | MLM |
| Date Received | 2018-07-23 |
| Catalog Number | DF207 SMN 10700795 |
| Lot Number | GA9106 |
| Device Expiration Date | 2019-04-16 |
| 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 INC. |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-23 |