FDA Adverse Event
Malfunction
Summary report: N
DIMENSION
MDR report key: 697077
·
Received October 3, 2005
Report
- Report Number
- 1226181-2005-00098
- Event Type
- Malfunction
- Date Received
- October 3, 2005
- Date of Event
- September 12, 2005
- Report Date
- September 20, 2005
- Manufacturer
- DADE BEHRING, INC.
- Product Code
- MMI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A FALSELY ELEVATED TROPONIN RESULT WAS OBTAINED ON THE DIMENSION RLMAX ANALYZER. THE RESULT OBTAINED WAS 0.63 NG/ML. THE RESULT WAS NOT CONSISTENT WITH OTHER CARDIAC MARKERS: CK RESULT WAS 101 U/ML (NORMAL); MMB (CKB) RESULT WAS, 0.5 NG/ML (NORMAL). REPAIR TESTING OF TROPONIN ON AN ALTERNATE DIMENSION ANALYZER WAS 0.00 NG/ML. THERE WAS NO ADVERSE HEALTH EFFECTS DUE TO THE ERRONEOUS RESULT BEING REPORTED TO THE PHYSICIAN. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. A DADE BEHRING REPRESENTATIVE MADE MECHANICAL ADJUSTMENTS TO THE INSTRUMENT TO CORRECT THE IMPRECISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIMENSION | CLINICAL CHEMISTRY SYSTEM | MMI | DADE BEHRING, INC. | RXLMAX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |