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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, INC PREVI ISOLA(TM) INSTRUMENT
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BIOMERIEUX, INC PREVI ISOLA(TM) INSTRUMENT Back to Search Results
Catalog Number 29500
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
On (b)(6) 2016 a customer reported receiving no growth on urinalysis results while using; previ isola(tm) instrument hp rp5700.On (b)(6) 2016 there was a report of delayed urosepsis diagnosis.
 
Manufacturer Narrative
This report was initially submitted following notification from a customer in the united states regarding no growth obtained on urinalysis plates while using; previ isola(tm) instrument hp rp5700.A biomérieux investigation was initiated.After numerous requests by biomérieux for photos of the tested plates and the log files associated with the tests, neither log files, photos nor any other information sufficient to determine the root cause of the incident were provided.In addition, the customer stated that the issue was due to a user error.
 
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Brand Name
PREVI ISOLA(TM) INSTRUMENT
Type of Device
PREVI ISOLA(TM) INSTRUMENT
Manufacturer (Section D)
BIOMERIEUX, INC
595 anglum road
st. louis MO 63042
MDR Report Key5445568
MDR Text Key39136629
Report Number3002769706-2016-00032
Device Sequence Number1
Product Code LXG
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number29500
Initial Date Manufacturer Received 01/27/2016
Initial Date FDA Received02/18/2016
Supplement Dates Manufacturer Received06/01/2016
Supplement Dates FDA Received02/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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