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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 02/13/2019
Event Type  malfunction  
Event Description
The customer alleged that the meter produced smoke from the test strip slot of the device.No adverse event was reported.The blood glucose monitor was requested to be 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 Key8373450
MDR Text Key137245681
Report Number3011393376-2019-00769
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 consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number06870287001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/13/2019
Initial Date FDA Received02/27/2019
Supplement Dates Manufacturer Received06/25/2019
Supplement Dates FDA Received07/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage N
Patient Sequence Number1
Patient Age72 YR
Patient Weight75
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