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 2018-10-17 for DIMENSION? DF 167 SMN 10444957 manufactured by Siemens Healthcare Diagnostics Inc..
[124012876]
Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant, falsely depressed and falsely elevated total bilirubin (tbi) results. Hsc analysis of the instrument photometer data indicates the patient samples identified as the "neat" undiluted sample by the customer were actually the diluted sample. Conversely, patient samples identified by the customer as the diluted sample were actually the "neat" undiluted sample. Hsc concludes the cause of the discordant tbi results was due to the use error of switching the order of the "neat" undiluted sample with the diluted sample in the segment locations on the instrument. Hsc has reviewed the information provided and concludes that it this event was not a reagent lot issue or an assay issue. There is no evidence of a product nonconformance. The device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[124012877]
Discordant, falsely depressed and discordant falsely elevated total bilirubin (tbi) results were obtained on a patient sample on the dimension exl system. The discordant results were not reported to the physician. The same samples were reprocessed the same day and a correct result was obtained. The correct result was reported to the physician. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed and falsely elevated tbi results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00571 |
| MDR Report Key | 7975101 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-17 |
| Date of Report | 2018-10-17 |
| Date of Event | 2018-09-21 |
| Date Mfgr Received | 2018-09-21 |
| Device Manufacturer Date | 2018-07-26 |
| Date Added to Maude | 2018-10-17 |
| 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? TOTAL BILIRUBIN FLEX? TBI REAGENT CARTRIDGE |
| Product Code | CIG |
| Date Received | 2018-10-17 |
| Catalog Number | DF 167 SMN 10444957 |
| Lot Number | FB9207 |
| Device Expiration Date | 2019-07-26 |
| 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 | 2018-10-17 |