FDA.reportPublic FDA data

MAUDE MDR 3424231

MDR report key
3424231
Report number
3424231
Event key
0
Event type
3
Date of event
2013-08-22
Date received
2013-09-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NOVA STATSTRIPGLUCOSE METER, BATTERYNOVA BIOMEDICAL CORP.FCOAS200146827* R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-09-120

Event Narratives#

D

Patient 1

AN ASSESSMENT WAS DONE OF METERS THROUGHOUT THE FACILITY. IT WAS NOTED THAT 14 OF THE 27 METERS HAD BATTERIES THAT WERE BULGING AND WOULD NOT ALLOW THE DOOR TO CLOSE PROPERLY ON THE METER. A NOVA CLINICAL SPECIALIST HELPED THE FACILITY IDENTIFY THIS PROBLEM. ALL OF THE BATTERIES ARE SUPPLIED THROUGH NOVA BIOMEDICAL, HOWEVER, THEY ARE MANUFACTURED BY FORMOSA ELECTRONIC INDUSTRIES, INC. (RECHARGEABLE LI-POLYMER BATTERY PACK, DC 3.7V). ALSO, THE FACILITY USES ANOTHER BATTERY MANUFACTURED BY A&S ENERGY CO., LTD. (MODEL AS2001, DC 3.7V, EXPIRATION DATE 11/13) HOWEVER THESE BATTERIES DO NOT BULGE AT ALL. WHEN THE METERS WERE FIRST IMPLEMENTED IN SPRING OF 2013, NOVA DID NOT INFORM THE FACILITY THAT THERE HAD BEEN PROBLEMS WITH THE BATTERIES AND THAT THE BATTERIES HAVE EXPIRATION DATES. ALSO OF NOTE IS THAT THE METERS WITH SWOLLEN BATTERIES SHOW THE LIGHTS ON THE RIGHT SIDE OF THE DOCKING STATION TO BE AMBER IN COLOR.