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 2018-09-27 for DIMENSION VISTA? K3056 SMN 10461745 manufactured by Siemens Healthcare Diagnostics Inc..
[122173132]
The customer contacted the siemens customer care center (ccc) for the discordant depressed lipl results. Siemens headquarters support center (hsc) has reviewed the information provided by the customer. The customer stated that a new flex was loaded onto the instrument and qc was within range. The event is isolated to one flex reagent cartridge of lot 18040ba. Using a new flex resolved the issue. No error flags were generated at the time of testing. Hsc is not able to determine the cause of the low recovery with this flex. Instrument data is not available. There is no evidence of a product non-conformance. The system is working as specified with the new flex. The cause is unknown. The device is operating within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[122173133]
Discordant falsely depressed lipase (lipl) results were obtained on qc and patient samples on the dimension vista 500 system. The results were reported to the physician(s). The patient samples were reprocessed due to qc being out of laboratory ranges. Higher results and within range qc values were obtained on the same samples on an alternate dimension vista and on reprocessing on the original dimension vista with a new flex reagent cartridge from the same lot. Corrected patient results were reported. There are no reports of treatment change or adverse health consequences to the patients due to the discordant falsely depressed lipl results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00546 |
| MDR Report Key | 7915178 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-27 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-09-13 |
| Date Mfgr Received | 2018-09-13 |
| Device Manufacturer Date | 2018-02-09 |
| Date Added to Maude | 2018-09-27 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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? LIPL LIPASE FLEX? REAGENT CARTRIDGE |
| Product Code | CHI |
| Date Received | 2018-09-27 |
| Catalog Number | K3056 SMN 10461745 |
| Lot Number | 18040BA |
| Device Expiration Date | 2018-11-06 |
| 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 | 2018-09-27 |