MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-12 for DIMENSION? DF17A SMN 10444965 manufactured by Siemens Healthcare Diagnostics Inc..
[105522951]
Mdr 2517506-2018-00260 was also filed for the same amy event. The customer contacted siemens customer care center (ccc) and reported that a discordant, falsely elevated amylase (amy) patient result was obtained on the dimension rxl max hm system. Siemens is investigating the incident.
Patient Sequence No: 1, Text Type: N, H10
[105522952]
A discordant, falsely elevated amylase (amy) result was obtained on a patient sample on the dimension rxl max hm system. The result was reported to the physician who questioned the result. The same sample was tested on the same instrument at a later date and an elevated result was obtained. The patient was hospitalized for suspected pancreatitis. There are no reports of patient intervention or adverse health consequences due to the discordant elevated amy result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00258 |
| MDR Report Key | 7427108 |
| Date Received | 2018-04-12 |
| Date of Report | 2018-06-13 |
| Date of Event | 2018-03-14 |
| Date Mfgr Received | 2018-05-21 |
| Device Manufacturer Date | 2017-10-26 |
| Date Added to Maude | 2018-04-12 |
| 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 | 0 |
| Brand Name | DIMENSION? |
| Generic Name | DIMENSION? AMY AMYLASE FLEX? REAGENT CARTRIDGE |
| Product Code | JFJ |
| Date Received | 2018-04-12 |
| Catalog Number | DF17A SMN 10444965 |
| Lot Number | EA8299 |
| Device Expiration Date | 2018-10-26 |
| 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 | 2018-04-12 |