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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIPRO DIAGNOSTICS, INC. BLOOD GLUCOSE SYSTEM

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NIPRO DIAGNOSTICS, INC. BLOOD GLUCOSE SYSTEM Back to Search Results
Model Number TRUEPLUS
Device Problems Product Quality Problem (1506); Packaging Problem (3007)
Patient Problem Irritation (1941)
Event Date 01/08/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Customer discarded the box and remaining syringes - the customer has no product to return. Most likely underlying root cause of malfunction: failure to follow instructions/manufacturing deficiency.
 
Event Description
Customer stated that when she opened the bag of syringes, one of the syringes poked her between her fingers. Customer states the orange cap was missing from the syringe and as well as the package. She was very concerned that the needle was not sterile. Customer stated she was concerned at the time needle poked her because her finger was irritated, but at this time the area poked is no longer irritated. Customer did not seek medical attention due to this incident.
 
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Type of DeviceBLOOD GLUCOSE SYSTEM
Manufacturer (Section D)
NIPRO DIAGNOSTICS, INC.
2400 nw 55th court
fort lauderdale FL 33309
Manufacturer Contact
karen devincent
2400 nw 55th court
fort lauderdale, FL 33309
954677-920
MDR Report Key5411219
MDR Text Key37527845
Report Number1052693-2016-00219
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K993017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Remedial Action Replace
Type of Report Initial
Report Date 02/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTRUEPLUS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Event Location Hospital
Date Manufacturer Received01/08/2016
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 Initial

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