inforMED
MalfunctionDEX

GLUCOMETER DEX

Received Dec 10, 2004 · Event occurred Nov 12, 2004

Report 1810909-2004-00359 · MDR key 794281

Device

Generic name

Blood Glucose Meter

Model number

3952E

Catalog number

*

Lot number

*

Product problems

  • Replace
  • Component Missing
  • Device Issue

Patient

UNKNOWN

  • Unknown (for use when the patient's condition is not known)

Narrative

Additional Manufacturer Narrative

UPON RECEIPT, PERFORMANCE TESTING WAS CONDUCTED. TESTING DETERMINED THAT SEGMENTS WERE MISSING IN THE 100'S, 10'S AND UNIT'S POSITIONS OF THE DISPLAY - THE COMPLAINT WAS CONFIRMED. A ROOT CAUSE ANALYSIS WILL BE PERFORMED AND IF ANYTHING OF SUBSTANCE RESULTS FROM THIS ANALYSIS IT WILL BE REPORTED TO THE AGENCY. THIS COMPLAINT IS CONSIDERED CLOSED FOR PURPOSES OF MDR.

Description of Event or Problem

THE CUSTOMER STATED THAT THE DISPLAY WAS NOT WORKING. A REVIEW OF THE SYSTEM WAS CONDUCTED OVER THE PHONE. THIS REVIEW INDICATED THAT SEGMENTS WERE MISSING FROM THE DISPLAY. THE CUSTOMER WAS ASKED TO RETURN THE METER FOR FURTHER EVALUATION AND A REPLACEMENT WAS PROVIDED. THE CUSTOMER WAS INVITED TO CALL WITH FUTURE QUESTIONS/CONCERNS.