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 2018-06-04 for DIMENSION? DF56 SMN 10460277 manufactured by Siemens Healthcare Diagnostics Inc..
[109910599]
The customer contacted the siemens customer care center (ccc) for the discordant elevated lipl result obtained on the initial sample on the dimension exl system. Siemens headquarters support center (hsc) has reviewed the instrument data and completed their evaluation. Hsc does not suspect an instrument or reagent issue as qc is very consistent. System checks were all within range. No product non-conformances were identified. The cause is unknown. The system is operating within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[109910605]
A discordant elevated lipase (lipl) result was obtained on a patient sample on the dimension exl 200 system. The result was reported to the physician who questioned the result. The patient had a new sample drawn at a later time on the same date and a lower result was obtained and reported. No corrected report was issued. The patient was admitted based on the symptoms and laboratory result of the elevated lipase for evaluation and fluids (suspected pancreatitis). The patient was given nacl iv fluids. There are no reports of adverse health consequences due to the discordant elevated lipl result or treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00356 |
| MDR Report Key | 7565063 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-04 |
| Date of Report | 2018-07-03 |
| Date of Event | 2018-05-09 |
| Date Mfgr Received | 2018-06-06 |
| Device Manufacturer Date | 2018-02-13 |
| Date Added to Maude | 2018-06-04 |
| 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? |
| Generic Name | DIMENSION? LIPL LIPASE FLEX? REAGENT CARTRIDGE |
| Product Code | CHI |
| Date Received | 2018-06-04 |
| Catalog Number | DF56 SMN 10460277 |
| Lot Number | GC8317 |
| Device Expiration Date | 2018-11-13 |
| 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 | 2018-06-04 |