MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-01 for DIMENSION? CLINICAL CHEMISTRY SYSTEM RXL MAX HM manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[2733734]
A falsely depressed gentamicin (gent) result was obtained on a low level quality control sample. During the period when the level 1 qc was below the lab's established range for the control, reports had been reported to physicians. Other levels of qc were within acceptance ranges of the facility. 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 gent qc results.
Patient Sequence No: 1, Text Type: D, B5
[10086521]
Analysis of the instrument and instrument data indicate that the cause for the falsely depressed gent qc result was non-standard use of the instrument and failure to follow instructions. The account did not recalibrate the gent method after replacement of the source lamp. The dimension rxl operator's guide instructs operators: "you must calibrate the light dependent methods... When the source lamp is replaced. " gent is listed among the light dependent methods. A siemens healthcare diagnostics field service engineer (fse) was dispatched to the account to evaluate the lamp and filter systems. The instrument is performing within specifications. No further evaluation of the device is required
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226181-2012-00040 |
| MDR Report Key | 2677802 |
| Report Source | 05,06 |
| Date Received | 2012-08-01 |
| Date of Report | 2012-07-11 |
| Date of Event | 2012-07-11 |
| Date Mfgr Received | 2012-07-11 |
| Device Manufacturer Date | 2005-01-27 |
| Date Added to Maude | 2012-11-23 |
| 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- BROOKFIELD |
| Manufacturer Street | 101 SILVERMINE ROAD |
| Manufacturer City | BROOKFIELD CT 06804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06804 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION? CLINICAL CHEMISTRY SYSTEM |
| Generic Name | CLINICAL CHEMISTRY SYSTEM |
| Product Code | LCD |
| Date Received | 2012-08-01 |
| Model Number | RXL MAX HM |
| 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 | 2012-08-01 |