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 2018-08-22 for DIMENSION VISTA? K1167 SMN 10445146 manufactured by Siemens Healthcare Diagnostics Inc..
[118255655]
Mdr 2517506-2018-00456 was also filed for the same event. The customer contacted the siemens customer care center (ccc) about a discordant depressed patient total bilirubin (tbil) result obtained on the dimension vista. Siemens headquarters support center (hsc) completed their evaluation of the event. Hsc examined the instrument data logs and confirmed that the hemoglobin concentration in the sample was well above the instructions for use (ifu) limit and was appropriately flagged. It correlates with the hemoglobin (h) recovery for the hil flag. Results with a hemoglobin error are not reportable. The tbil ifu limitations of procedure section states: "any report containing flags and/or comments should be addressed according to your laboratory's procedure manual and not reported. " the device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[118255656]
A discordant falsely depressed total bilirubin (tbil) result was obtained on a patient sample on the dimension vista 1500 system. The result was flagged for hemolysis (e111 flag) but was reported to the physician. A new sample drawn the same day was processed and a higher result was obtained consistent with the clinical picture and reported. There are no known reports of patient intervention or adverse health consequences due to the discordant depressed tbil result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00457 |
| MDR Report Key | 7806482 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-22 |
| Date of Report | 2018-08-22 |
| Date of Event | 2018-07-31 |
| Date Mfgr Received | 2018-08-01 |
| Device Manufacturer Date | 2018-05-04 |
| Date Added to Maude | 2018-08-22 |
| 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 VISTA? |
| Generic Name | DIMENSION VISTA? TBIL TOTAL BILIRUBIN FLEX? REAGENT CARTRIDGE |
| Product Code | CIG |
| Date Received | 2018-08-22 |
| Catalog Number | K1167 SMN 10445146 |
| Lot Number | 18123BA |
| Device Expiration Date | 2019-05-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-08-22 |