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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® AVIVA PLUS TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS
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ROCHE DIABETES CARE, INC. ACCU-CHEK ® AVIVA PLUS TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS Back to Search Results
Model Number 06908373001
Medical Device Problem Code Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/18/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Case with patient identifier (b)(6) is related to case with patient identifier (b)(6).
 
Event or Problem Description
It was reported the patient received the following results within 10 minutes: 46 mg/dl on aviva meter and 107 mg/dl on guide meter.
 
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Brand Name
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
Common Device Name
BLOOD GLUCOSE MONITORING TEST STRIPS
Manufacturer (Section D)
ROCHE DIABETES CARE, INC.
9115 hague road
indianapolis IN 46250 0457
MDR Report Key9472947
Report Number3011393376-2019-04490
Device Sequence Number2752014
Product Code NBW
UDI-Device Identifier00365702436107
UDI-Public00365702436107
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K101299
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 02/18/2020
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
Operator of Device Lay User/Patient
Device Expiration Date01/31/2020
Device Model Number06908373001
Device Catalogue Number06908373001
Device Lot Number497818
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/21/2019
Supplement Date Received by Manufacturer01/30/2020
Initial Report FDA Received Date12/16/2019
Supplement Report FDA Received Date02/18/2020
Patient Sequence Number1
Patient Age49 YR
Patient Weight88
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