MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-12-11 for DIMENSION VISTA? K6435 SMN10488927 manufactured by Siemens Healthcare Diagnostics Inc.
[94499700]
Mdr 2517506-2017-00861, mdr 2517506-2017-00862, mdr 2517506-2017-00863, mdr 2517506-2017-00864, mdr 2517506-2017-00865, mdr 2517506-2017-00866, mdr 2517506-2017-00867, mdr 2517506-2017-00868, mdr 2517506- 2017-00869, mdr 2517506-2017-00870, mdr 2517506-2017-00872, mdr 2517506-2017-00873, mdr 2517506-2017-00874, mdr 2517506-2017-00875 were also filed for the same customer inquiry. The customer contacted siemens customer care center for the discordant elevated digoxin result on the dimension vista instrument. Quality control was within specification during testing. Siemens is investigating the incident.
Patient Sequence No: 1, Text Type: N, H10
[94499701]
A discordant falsely elevated digoxin (digxn) result was obtained on a patient sample on the dimension vista 1500 instrument. The result was reported to the physician who questioned the result. The same sample was tested twice earlier on an alternate vista instrument and high results were obtained. The same sample was repeated three times later on the same vista instrument and high results were obtained. A 1:3 and 1:2 manual dilution was performed on the last two repeats and high results were obtained on the same sample. The clinician started to question the result since it had increased when no digoxin was given to the patient. There is no known report of patient adverse health consequences due to the discordant falsely elevated digxn result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00871 |
| MDR Report Key | 7103746 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-11 |
| Date of Report | 2018-01-19 |
| Date of Event | 2017-11-10 |
| Date Mfgr Received | 2018-01-04 |
| Device Manufacturer Date | 2017-04-14 |
| Date Added to Maude | 2017-12-11 |
| 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? DIGXN LOCI DIGOXIN FLEX? REAGENT CARTRIDGE |
| Product Code | KXT |
| Date Received | 2017-12-11 |
| Catalog Number | K6435 SMN10488927 |
| Lot Number | 17103BC |
| Device Expiration Date | 2018-04-13 |
| 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 | 2017-12-11 |