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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR 6-TEST 50 STR.; URINE TEST STRIPS
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ROCHE DIAGNOSTICS COMBUR 6-TEST 50 STR.; URINE TEST STRIPS Back to Search Results
Catalog Number 11896962257
Device Problem Non Reproducible Results (4029)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/02/2019
Event Type  malfunction  
Manufacturer Narrative
The reporter's product was requested for investigation.
 
Event Description
The initial reporter stated that they received discrepant results for an unspecified number of patients tested for nitrite using combur 6 test strips.All patients that were tested had positive nitrite results when using strips from one vial.Testing was repeated using a new package/vial of test strips from the same lot and all nitrite results were negative.
 
Manufacturer Narrative
The customer was unable to provide the affected material for investigation.Retention lot of strips were visually checked and showed no abnormalities and no signs of discoloration.No false positive results were observed.The investigation did not identify a product problem.The cause of the event could not be determined.
 
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Brand Name
COMBUR 6-TEST 50 STR.
Type of Device
URINE TEST STRIPS
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key8911137
MDR Text Key175718387
Report Number1823260-2019-03045
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 12/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number11896962257
Device Lot Number36897602
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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