MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-05 for DIMENSION? DIGOXIN FLEX REAGENT CARTRIDGE DF35A SMN10444941 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[42438141]
Analysis of the instrument and instrument data indicate that the cause for the questioned, elevated dgna result is unknown. The complaint was submitted by the customer as an inquiry whether the elevation could be due to interaction with the patient's multiple medications. The issue is under investigation by siemen healthcare diagnostics.
Patient Sequence No: 1, Text Type: N, H10
[42438142]
The customer questioned as discrepant an elevated digoxin (dgna) result on a patient sample on the dimension instrument. The result was reported to the physician who later questioned the result on the basis of a result obtained on a new specimen drawn later in the same day. The patient was hospitalized on the basis of the elevated dgna result. There is no indication that patient treatment was otherwise altered or prescribed on the basis of the questioned, elevated dgna result. There was no report of adverse health consequences as a result of the questioned, elevated dgna result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2016-00226 |
| MDR Report Key | 5548777 |
| Date Received | 2016-04-05 |
| Date of Report | 2017-12-11 |
| Date of Event | 2016-03-10 |
| Date Mfgr Received | 2017-11-20 |
| Device Manufacturer Date | 2015-09-18 |
| Date Added to Maude | 2016-04-05 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE |
| Manufacturer City | NEWARK DE 19714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DIMENSION? DIGOXIN FLEX REAGENT CARTRIDGE |
| Generic Name | DIMENSION? DIGOXIN DGNA FLEX REAGENT CARTRIDGE |
| Product Code | KXT |
| Date Received | 2016-04-05 |
| Catalog Number | DF35A SMN10444941 |
| Lot Number | BA6262 |
| Device Expiration Date | 2016-09-18 |
| Operator | MEDICAL TECHNOLOGIST |
| 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 - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE NEWARK DE 19714 US 19714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-05 |