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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PTS DIAGNOSTICS PTS PANELS GLUCOSE TEST STRIPS; CLINICAL CHEMISTRY GLUCOSE TEST STRIP
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PTS DIAGNOSTICS PTS PANELS GLUCOSE TEST STRIPS; CLINICAL CHEMISTRY GLUCOSE TEST STRIP Back to Search Results
Lot Number U302
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2023
Event Type  malfunction  
Event Description
The customer reported receiving abnormally low glucose results during a screening which would come back as a normal value upon being sent out for laboratory testing.There were no allegations of patient/user harm.
 
Manufacturer Narrative
This event is being reported out of an abundance of caution due to the anticipation of customer product which would provide additional data for analysis.The screener received questionable results (not believable values) and properly sent for a lab value.There were no allegations of patient/user harm.
 
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Brand Name
PTS PANELS GLUCOSE TEST STRIPS
Type of Device
CLINICAL CHEMISTRY GLUCOSE TEST STRIP
Manufacturer (Section D)
PTS DIAGNOSTICS
4600 anson blvd
whitestown IN
Manufacturer (Section G)
PTS DIAGNOSTICS
4600 anson blvd
whitestown IN
Manufacturer Contact
brandon unruh
4600 anson blvd
whitestown, IN 
3178705610
MDR Report Key18187124
MDR Text Key328942418
Report Number1836135-2023-00044
Device Sequence Number1
Product Code CGA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013068
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 11/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberU302
Was Device Available for Evaluation? No
Date Manufacturer Received10/26/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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