FDA Adverse Event
Other
Summary report: N
ADVIA CHEMISTRY TRIGLYCERIDE METHOD
MDR report key: 1051297
·
Received May 22, 2008
Report
- Report Number
- 2432235-2008-00047
- Event Type
- Other
- Date Received
- May 22, 2008
- Date of Event
- April 18, 2008
- Report Date
- April 21, 2008
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS, INC.
- Product Code
- JGY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DISCUSSIONS WITH THE OEM REAGENT MANUFACTURER INDICATES THAT ADVIA CHEMISTRY TRIGLYCERIDE LOT 095939 IS EXHIBITING LOWER THAN EXPECTED LINEARITY AND ROOT CAUSE INVESTIGATION IS UNDER WAY BY THE MANUFACTURER.
Description of Event or Problem · 1
CUSTOMER REPORTED DISCORDANT TRIGLYCERIDE RESULTS FOR SEVERAL PATIENTS WHEN THEY SWITCHED FROM TRIGLYCERIDE REAGENT LOT 095939 TO LOT 102610. UPON REVIEW OF THE SAMPLES RUN WITH LOT 095939, THE CUSTOMER FOUND THAT THERE WERE NO ELEVATED RESULTS REPORTED WITH THIS REAGENT LOT. A REVIEW OF SAMPLES RUN WITH THE DIFFERENT REAGENT LOT (102610) THE CUSTOMER FOUND SEVERAL SAMPLES READING OVER THEIR RERUN POINT OF 6.22 MMOL/L. IT IS UNKNOWN AT THIS TIME IF THERE WAS ANY PATIENT INTERVENTION AS A RESULT OF THESE DISCORDANT TRIGLYCERIDE RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVIA CHEMISTRY TRIGLYCERIDE METHOD | TRIGLYCERIDE METHOD | JGY | SIEMENS HEALTHCARE DIAGNOSTICS, INC. | NA | REAGENT 095939 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |