MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-13 for DIMENSION VISTA? LIPASE FLEX? REAGENT CARTRIDGE K3056 (SMN # 10461745) manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[72944966]
Customer contacted siemens customer care center (ccc) and accepted remote access. Ccc determined that the low lipl results occurred with lipl flex reagent cartridge sequence number 6829 in wellmap 1:7. Ccc directed customer to replace the reagent cartridge with another reagent cartridge from the same lot and run qc. Qc passes and customer reran lipl on patient samples and issued corrected reports on eleven of the fifteen samples that were rerun. The cause of low lipl results on the affected reagent cartridge is unknown. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[72944967]
Discordant lipase (lipl) results were obtained on qc and patient samples on the dimension vista 500 system. Patient results were reported to physician(s) while qc was out of range. There is no indication that patient results were questioned by the physician(s). After recalibration and passing qc results, the same patient samples were repeated on the same system. Corrected reports were issued on eleven of the fifteen samples. There are no known reports of patient intervention or adverse health consequences due to the initially discordant lipl results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00359 |
| MDR Report Key | 6489543 |
| Date Received | 2017-04-13 |
| Date of Report | 2017-04-13 |
| Date of Event | 2017-03-20 |
| Date Mfgr Received | 2017-03-22 |
| Device Manufacturer Date | 2016-06-27 |
| Date Added to Maude | 2017-04-13 |
| 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 | PH.D EDWARD SZYMANSKI |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026317672 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC - GLASGOW |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 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 VISTA? LIPASE FLEX? REAGENT CARTRIDGE |
| Generic Name | DIMENSION VISTA? LIPL |
| Product Code | CHI |
| Date Received | 2017-04-13 |
| Catalog Number | K3056 (SMN # 10461745) |
| Lot Number | 16179BC |
| Device Expiration Date | 2017-03-24 |
| 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 - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-13 |