MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-10-24 for DIMENSION VISTA? CLINICAL CHEMISTRY SYSTEM K1027 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[17564398]
Falsely depressed cholesterol (chol) results were obtained on patient samples. Results were reported to the physician. The results were questioned within the laboratory due to occasional abnormal reaction flags on chol tests. The samples were re-run and higher results were obtained. Corrected results were reported on the patient samples. It is unknown if patient treatment was altered or prescribed. There was no report of adverse health consequences as a result of the falsely depressed chol results.
Patient Sequence No: 1, Text Type: D, B5
[17670583]
Analysis of the instrument and instrument data indicate that the cause for the falsely depressed cholesterol results is incomplete hydration of the reagent cartridge well. The siemens healthcare diagnostics technical service center representative directed the customer to follow recommended prehydration of the reagent cartridge well. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2012-00282 |
| MDR Report Key | 2803258 |
| Report Source | 05,06 |
| Date Received | 2012-10-24 |
| Date of Report | 2012-09-25 |
| Date of Event | 2012-09-24 |
| Date Mfgr Received | 2012-09-25 |
| Device Manufacturer Date | 2012-06-11 |
| Date Added to Maude | 2013-02-04 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE |
| Manufacturer City | NEWARK DE 19702 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19702 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA? CLINICAL CHEMISTRY SYSTEM |
| Generic Name | CHOLESTEROL FLEX? REAGENT CARTRIDGE |
| Product Code | CHH |
| Date Received | 2012-10-24 |
| Catalog Number | K1027 |
| Lot Number | 12163BB |
| Operator | MEDICAL TECHNOLOGIST |
| 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 NEWARK DE 19702 US 19702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-24 |