MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-11-20 for DIMENSION VISTA? CLINICAL CHEMISTRY SYSTEM K6444 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[16129041]
Falsely elevated folate (fol) results were obtained on multiple patient samples. The patient results were reported to the physician. Repeats were run after correction of a calibration error and lower folate results were obtained and reported. It is unknown if patient treatment was altered or prescribed. There was no report of adverse health consequences as a result of the falsely elevated folate results.
Patient Sequence No: 1, Text Type: D, B5
[16328591]
Analysis of the instrument and instrument data indicate that the cause for the falsely elevated folate results is user error. The account had entered the calibrator values for the incorrect unit of measure (nmol/l) rather than the correct unit of measure (ng/ml). The siemens healthcare diagnostics inc technical service center representative directed the customer to enter the correct unit of measure values for the calibrators and to recalibrate. This resolved the issue. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2012-00308 |
| MDR Report Key | 2839781 |
| Report Source | 05,06 |
| Date Received | 2012-11-20 |
| Date of Report | 2012-10-16 |
| Date of Event | 2012-10-16 |
| Date Mfgr Received | 2012-10-16 |
| Device Manufacturer Date | 2012-07-06 |
| Date Added to Maude | 2013-02-26 |
| 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 | FOLATE FLEX? REAGENT CARTRIDGE |
| Product Code | CGN |
| Date Received | 2012-11-20 |
| Catalog Number | K6444 |
| Lot Number | 12188AA |
| Device Expiration Date | 2013-07-06 |
| 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 | 2012-11-20 |