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 2017-12-19 for DIMENSION VISTA? K5088 SMN 10445110 manufactured by Siemens Healthcare Diagnostics Inc.
[96021350]
The customer contacted the siemens customer care center (ccc) about the discordant falsely elevated actm result. The ccc instructed the customer that the cause of the discordant falsely elevated result was user error in reporting a diluted result after a below assay range flagged original result. Dilution of a flagged below assay range sample is not prescribed in the actm instructions for use (ifu). The issue was resolved by customer education. Additionally, the sample was flagged for icterus interference both initially and on dilution: the actm instructions for use states in the limitations of procedure section: 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 acetaminophen 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 device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[96021351]
A discordant falsely elevated, acetaminophen (actm) result was obtained on a patient sample on the dimension vista 500 instrument. The result was reported to the physician. The result was questioned by the physician. The customer stated that the patient was treated based on the discordant falsely elevated result on their belief of an acetaminophen overdose. It is unknown what treatment was provided to the patient. There are no known reports of adverse health consequences due to the discordant result or treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00877 |
| MDR Report Key | 7130825 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-12-19 |
| Date of Report | 2017-12-19 |
| Date of Event | 2017-11-24 |
| Date Mfgr Received | 2017-11-25 |
| Device Manufacturer Date | 2017-07-23 |
| Date Added to Maude | 2017-12-19 |
| 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 | 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? ACTM ACETAMINOPHEN FLEX? REAGENT CARTRIDGE |
| Product Code | LDP |
| Date Received | 2017-12-19 |
| Catalog Number | K5088 SMN 10445110 |
| Lot Number | 17205AA |
| Device Expiration Date | 2018-07-24 |
| 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 | 2017-12-19 |