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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HIV COMBI PT; HIV DETECTION TEST
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ROCHE DIAGNOSTICS ELECSYS HIV COMBI PT; HIV DETECTION TEST Back to Search Results
Model Number HIV COMBI
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/30/2020
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).
 
Event Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys hiv combi pt on a cobas 6000 e 601 module.No incorrect results were reported outside of the laboratory.The sample was tested three times on the e 601 analyzer, resulting with values of 0.021 coi (non-reactive), 0.007 coi (non-reactive), and 0.012 coi (non-reactive).The sample was repeated using an unknown competitor method, resulting with a value of 7.7 coi (reactive).The serial number of the e 601 analyzer is (b)(4).
 
Manufacturer Narrative
The investigation could not identify a product problem.The cause of the event could not be determined.
 
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Brand Name
ELECSYS HIV COMBI PT
Type of Device
HIV DETECTION TEST
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key9717542
MDR Text Key220285129
Report Number1823260-2020-00462
Device Sequence Number1
Product Code MZF
Combination Product (y/n)N
PMA/PMN Number
BP160050
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 03/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2020
Device Model NumberHIV COMBI
Device Catalogue Number05390095190
Device Lot Number40616601
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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