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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 54794
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/24/2019
Event Type  malfunction  
Manufacturer Narrative
No patient impact or adverse event reported.Investigation is on-going.
 
Event Description
The statstrip hospital meter, sn (b)(4) , read the patient's armband (b)(6) instead of (b)(6).No patient results were reported under wrong id.No patient impact or adverse event reported.
 
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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 3654
Manufacturer (Section G)
NOVA BIOMEDICAL CORP
200 prospect st.
waltham MA 02454 3654
Manufacturer Contact
mariya cesnulevicius
200 prospect st.
waltham, MA 02454-3654
7816473700
MDR Report Key9215867
MDR Text Key190820800
Report Number1219029-2019-00054
Device Sequence Number1
Product Code PZI
UDI-Device Identifier00385480547901
UDI-Public00385480547901
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K181043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number54794
Device Catalogue Number54790
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/24/2019
Initial Date FDA Received10/21/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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