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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR 4; URINARY GLUCOSE (NONQUANTITATIVE) TEST SYSTEM
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ROCHE DIAGNOSTICS COMBUR 4; URINARY GLUCOSE (NONQUANTITATIVE) TEST SYSTEM Back to Search Results
Model Number COMBUR 4
Device Problem Missing Information (4053)
Patient Problem No Patient Involvement (2645)
Event Date 11/26/2019
Event Type  malfunction  
Manufacturer Narrative
The vial was returned for investigation and replacement product was sent to the reporter.The vial contained 32 out of 50 test strips and the test strips show signs of discoloration on the glucose, nitrite, and protein test pads.The vial label was missing the expiration date and lot number information.This event occurred in (b)(6).
 
Event Description
The initial reporter stated they received 1 vial of combur 4 test strips that had the lot number and expiration date information missing from the vial label.The test strips appeared to be in use as there were only 30-32 test strips out of 50 remaining.
 
Manufacturer Narrative
The customer material was provided without the outer carton which was necessary for further evaluation.The investigation determined that this issue is non systemic.The cause of the event could not be determined.
 
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Brand Name
COMBUR 4
Type of Device
URINARY GLUCOSE (NONQUANTITATIVE) TEST SYSTEM
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key9543934
MDR Text Key215133791
Report Number1823260-2020-00016
Device Sequence Number1
Product Code JIL
Combination Product (y/n)N
PMA/PMN Number
K032437
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 07/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCOMBUR 4
Device Catalogue Number11896822191
Device Lot NumberASKU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2019
Date Manufacturer Received12/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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