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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. STATSTRIP GLUCOSE HOSPITAL METER SYSTEM; GLUCOSE TEST SYSTEM
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NOVA BIOMEDICAL CORP. STATSTRIP GLUCOSE HOSPITAL METER SYSTEM; GLUCOSE TEST SYSTEM Back to Search Results
Model Number 42214
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/02/2019
Event Type  malfunction  
Manufacturer Narrative
Investigation ongoing.
 
Event Description
On (b)(6) 2019: discrepant glucose patient results using nova statstrip hospital meter when compared to lab reference analyzer.
 
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Brand Name
STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Type of Device
GLUCOSE TEST SYSTEM
Manufacturer (Section D)
NOVA BIOMEDICAL CORP.
200 prospect st
waltham MA 02454 3465
Manufacturer (Section G)
NOVA BIOMEDICAL CORP.
200 prospect st
waltham MA 02454 3465
Manufacturer Contact
taylor ward
200 prospect st
waltham, MA 02454-3465
7816473700
MDR Report Key8740563
MDR Text Key151912296
Report Number1219029-2019-00028
Device Sequence Number1
Product Code PZI
UDI-Device Identifier10385480422144
UDI-Public10385480422144
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K181043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/16/2020
Device Model Number42214
Device Lot Number0318136309
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/04/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/16/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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