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 2019-02-07 for DIMENSION VISTA? K1039 SMN 10445162 manufactured by Siemens Healthcare Diagnostics Inc..
[138140965]
Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant, falsely depressed glucose result. The customer noted that the sample had a black discoloration. This was the only sample with this issue. The customer processed other samples without issue. Quality control (qc) was reprocessed after this patient sample and it was within laboratory ranges. Hsc concluded that this is not a reagent lot or assay issue. There is no evidence of a product nonconformance. There was no indication of foaming or reagent delivery issues based on the instrument data files. A siemens customer service engineer (cse) was dispatched to the customer account. Product maintenance was performed and no further discordant glucose results were observed. The device is performing within specifications. No further evaluation is required.
Patient Sequence No: 1, Text Type: N, H10
[138140966]
A discordant, falsely depressed glucose (glu) result was obtained on a patient sample on the dimension vista 500 system. The discordant result was not reported to the physician. The same sample was reprocessed the same day with an alternate, non-siemens methodology and a higher result was obtained and reported. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed glucose result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2019-00036 |
| MDR Report Key | 8316925 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-02-07 |
| Date of Report | 2019-02-07 |
| Date of Event | 2019-01-13 |
| Date Mfgr Received | 2019-01-13 |
| Device Manufacturer Date | 2018-09-19 |
| Date Added to Maude | 2019-02-07 |
| 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? GLUCOSE FLEX? REAGENT CARTRIDGE |
| Product Code | CFR |
| Date Received | 2019-02-07 |
| Catalog Number | K1039 SMN 10445162 |
| Lot Number | 18262BA |
| Device Expiration Date | 2019-09-19 |
| 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 | 2019-02-07 |