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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 03/12/2019
Event Type  malfunction  
Manufacturer Narrative
Patient was treated with glucose tablets/glucose gel.No adverse event was reported.No additional event or patient information is available, thus it is unknown if patient was a good candidate for a finger stick glucose test.Healthcare providers should be aware that a capillary whole blood specimen glucose result may not always be the same as an arterial or a venous whole blood glucose result.Evaluation of retain strips and dhr review was completed.The customer complaint cannot be replicated with retained strips.Evaluation of returned meter and strips is to be performed upon device return, expected 08/02/2019.
 
Event Description
Discrepant glucose patient results using nova statstrip xpress 2 glu/ket 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 Key8852439
MDR Text Key168215788
Report Number1219029-2019-00035
Device Sequence Number1
Product Code PZI
UDI-Device Identifier10385480422144
UDI-Public10385480422144
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K181043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date02/29/2020
Device Model Number42214
Device Lot Number0317233309
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 07/02/2019
Initial Date FDA Received08/01/2019
Date Device Manufactured08/21/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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