inforMED
MalfunctionDEX

GLUCOMETER DEX

Received Dec 10, 2004 · Event occurred Jun 3, 2004

Report 1810909-2004-00360 · MDR key 794293

Device

Generic name

Blood Glucose Meter

Model number

3952E

Catalog number

*

Lot number

*

Product problems

  • Replace
  • High Readings

Patient

UNKNOWN

  • Blood glucose, low

Narrative

Description of Event or Problem

CUSTOMER STATED THAT SHE TESTED WITH THIS METER AND COMPARED IT TO ANOTHER METER AND RECEIVED THE FOLLOWING RESULTS: @ 10:26PM - THIS METER = 103MG/DL, OTHER METER = 28 MG/DL, @ 10:36PM - THIS METER = 46MG/DL, OTHER METER = 34MG/DL, @ 11:07PM - THIS METER=106MG/DL, OTHER METER = 71MG/DL. A REVIEW OF THE SYSTEM WAS CONDUCTED OVER THE PHONE. THE REVIEW INDICATED THAT THE METER PERFORMED ACCORDING TO SPECIFICATIONS. THE CUSTOMER WAS ASKED TO RETURN THE METER FOR THE FURTHER EVALUATION AND A REPLACEMENT WAS PROVIDED. THE CUSTOMER WAS INVITED TO CALL WITH FUTURE QUESTIONS/CONCERNS.

Additional Manufacturer Narrative

UPON RECEIPTS, PERFORMANCE TESTING WAS CONDUCTED. TESTING DETERMINED THAT THE METER PERFORMED ACCORDING TO SPECIFICATIONS - THE COMPLAINT COULD NOT BE DUPLICATED. THIS COMPLAINS IS CONSIDERED CLOSED FOR PURPOSES OF MDR.