MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-30 for DIMENSION? CLINICAL CHEMISTRY SYSTEM RF420 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[3051951]
A falsely depressed low mmb result was obtained on a patient sample. The result was not reported to the physician. It was questioned within the lab. The sample was repeated and a higher result was obtained and reported. Patient treatment was not altered or prescribed as a result of the falsely depressed mmb result. There was no report of adverse health consequences as a result of the falsely depressed mmb result.
Patient Sequence No: 1, Text Type: D, B5
[10032742]
Analysis of the instrument and instrument data indicate that the cause for the falsely depressed mmb result is unknown. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2012-00193 |
| MDR Report Key | 2720618 |
| Report Source | 05,06 |
| Date Received | 2012-08-30 |
| Date of Report | 2012-08-02 |
| Date of Event | 2012-08-02 |
| Date Mfgr Received | 2012-08-02 |
| Device Manufacturer Date | 2012-03-21 |
| Date Added to Maude | 2012-12-17 |
| 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? CLINICAL CHEMISTRY SYSTEM |
| Generic Name | MASS CREATINE KINASE MB ISOENZYME FLEX? REAGENT CARTRIDGE |
| Product Code | JHY |
| Date Received | 2012-08-30 |
| Catalog Number | RF420 |
| Lot Number | DB3080 |
| Device Expiration Date | 2013-03-21 |
| 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 | 2012-08-30 |