FRT REAGENT
Received Dec 21, 2012 · Event occurred Jul 1, 2012
Report 2432235-2012-00455 · MDR key 2884154
Device
Generic name
Frt Reagent
Manufacturer
Siemens Healthcare DiagnosticsCatalog number
D129211
Lot number
219826
Product problems
- Improper or Incorrect Procedure or Method
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER RAN PATIENT SAMPLES WITH EXPIRED FERRITIN REAGENT. THE QUALITY CONTROLS WERE WITHIN RANGE AND THE PATIENT RESULTS WERE BELIEVABLE TO THE CUSTOMER. IT IS UNKNOWN IF PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO USE OF THE EXPIRED FERRITIN REAGENT.
Additional Manufacturer Narrative
THE CAUSE OF PATIENT SAMPLES BEING RUN WITH EXPIRED FERRITIN REAGENT IS USER ERROR. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.