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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 Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/30/2019
Event Type  malfunction  
Manufacturer Narrative
The affected product was requested for investigation.This event occurred in (b)(6).
 
Event Description
The initial reporter received questionable urine nitrite results for an unknown number of patient samples.The customer could not provide further information whether the results were false positive or false negative, but they stated the test pad is discolored to a light pink.It was unknown if any questionable results was reported outside of the laboratory.
 
Manufacturer Narrative
Additional information was requested for further investigation; however it was not provided.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 Key9346585
MDR Text Key219604229
Report Number1823260-2019-04115
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 02/05/2020
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 Number11896962257
Device Lot NumberASKU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/30/2019
Initial Date FDA Received11/20/2019
Supplement Dates Manufacturer Received10/30/2019
Supplement Dates FDA Received02/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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