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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® AVIVA; BLOOD GLUCOSE MONITORING DEVICE
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ROCHE DIABETES CARE, INC. ACCU-CHEK ® AVIVA; BLOOD GLUCOSE MONITORING DEVICE Back to Search Results
Catalog Number 06870287001
Device Problem Electrical Shorting (2926)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/15/2017
Event Type  malfunction  
Manufacturer Narrative
It was unknown if the initial reporter sent report to the fda.
 
Event Description
Upon review by the manufacturer's investigation unit, the display of the aviva meter was "marbled".No adverse event reported.The blood glucose monitor was returned for product evaluation.
 
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Brand Name
ACCU-CHEK ® AVIVA
Type of Device
BLOOD GLUCOSE MONITORING DEVICE
Manufacturer (Section D)
ROCHE DIABETES CARE, INC.
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
SANMINA-SCI CORPORATION
rathealy road
na
fermoy 00000
EI   00000
Manufacturer Contact
greg smith
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key6607776
MDR Text Key76517294
Report Number3011393376-2017-03157
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043474
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 10/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Medical Equipment Company Technician/Representative
Device Catalogue Number06870287001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received10/02/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage N
Patient Sequence Number1
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