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 2018-12-20 for DIMENSION VISTA? K1167 SMN10445146 manufactured by Siemens Healthcare Diagnostics Inc..
[131920177]
Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant, falsely depressed total bilirubin result. The tbil ifu indicates that any "report containing flags and/or comments should be addressed according to your laboratory's procedure and not reported": limitations of procedure: the instrument reporting system contains flags and comments to provide the user with information regarding instrument processing errors, instrument status information and potential errors in total bilirubin results. Refer to your dimension vista? Operator's guide for the meaning of report flags and comments. Any report containing flags and/or comments should be addressed according to your laboratory's procedure manual and not reported. The data indicates the system is flagging correctly for a hemolysis error and is working as specified. Hsc has reviewed the information provided and concludes that it is not a reagent lot or method issue. There is no evidence of a product nonconformance. The system is working as specified and flagging correctly for the presence of hemolysis for tbil samples. Hsc concludes the cause of this event of reporting of falsely low tbil results for sample id (b)(6) was due to operator error. The operator reported tbil results with e111: hemolysis error. Results with a hemoglobin error are not reportable. No product non-conformance was identified with the instrument or reagent. The device is performing within specifications. No further evaluation is required.
Patient Sequence No: 1, Text Type: N, H10
[131920178]
A discordant, falsely depressed total bilirubin result with a e111 hemolysis error flag was obtained on a neonate patient sample on the dimension vista instrument. The discordant result was reported to the physician(s) who questioned the result. A new sample drawn from the same patient was processed the next day on the original instrument and a higher result was obtained. A corrected report was issued. There are no known reports of patient intervention or adverse health consequences due to the discordant falsely depressed total bilirubin (tbil) result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00678 |
| MDR Report Key | 8185331 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-12-20 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-11-26 |
| Date Mfgr Received | 2018-11-27 |
| Device Manufacturer Date | 2018-08-21 |
| Date Added to Maude | 2018-12-20 |
| 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? TOTAL BILIRUBIN (TBIL) FLEX? REAGENT CARTRIDGE |
| Product Code | CIG |
| Date Received | 2018-12-20 |
| Catalog Number | K1167 SMN10445146 |
| Lot Number | 18233BH |
| Device Expiration Date | 2019-08-21 |
| 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 | 2018-12-20 |