J&J recalls glucose meter
April 4, 2013
Johnson & Johnson Medical has
announced a recall of its OneTouch
Verio IQ Blood Glucose Meter, after
consultation with the Therapeutic
Goods Administration.
The consumer-level recall will
see J&J replace all devices free of
charge, after they were found to
display incorrect readings in some
situations.
According to the TGA, it has been
found that at extremely high blood
glucose levels (56.8 mmol/L and
above) the device will turn off,
rather than display the intended
warning “EXTREME HIGH GLUCOSE
above 33.3 mmol/L”.
Once turned back on, the device
enters set-up mode and requires
the user to confirm the time and
date settings.
If another reading of 56.8 mmol/L
or above is then registered, the
device will turn off again.
“The likelihood of experiencing
blood glucose levels of 56.8 mmol/L
and above is remote.
“However such levels pose a
serious health risk to the patient
and require immediate attention.
“The identified fault in the
OneTouch Verio IQ Blood Glucose
Meter could lead to a delay
in diagnosis and treatment of
extremely high blood glucose levels
and, consequently, result in serious
injury,” the TGA said.
All patients who had previously
registered their meter for warranty
purposes have already been sent
a replacement device along with
further information.
Those who had not registered the
device should call 1800 543 372 to
organise a replacement.
In the meantime existing meters
can continue to be used, but if the
device unexpectedly turns off and
enters set-up mode immediate
medical attention should be sought.
J&J Medical has also written to
all diabetes nurse educators and
distributors it has on record, and
said that all OneTouch Verio IQ
Blood Glucose Meters in stock
should be quarantined before
making replacement arrangements.
More information for stockists
available on 1800 252 194.
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