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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE OMNI S; BLOOD GAS ANALYZER
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ROCHE DIAGNOSTICS ROCHE OMNI S; BLOOD GAS ANALYZER Back to Search Results
Catalog Number 03337154001
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/15/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).
 
Event Description
The customer received questionable low total hemoglobin (thb) results for two patient samples.Of the data provided only the results for one of the samples were discrepant.The initial result was 4.20 g/dl and was reported outside of the laboratory.The medical personnel decided to confirmed the results with an xt1800 analyzer and the result was 9.20 g/dl.No medical decisions based on the cobas b 221 result.There was no allegation of an adverse event.The reagent lot number and expiration date were requested but were not provided.
 
Manufacturer Narrative
The investigation was unable to find a definitive root cause.
 
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Brand Name
ROCHE OMNI S
Type of Device
BLOOD GAS ANALYZER
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key7391458
MDR Text Key104745990
Report Number1823260-2018-01001
Device Sequence Number1
Product Code CHL
Combination Product (y/n)N
PMA/PMN Number
K032311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup,Followup
Report Date 04/25/2018
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 Number03337154001
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/15/2018
Initial Date FDA Received04/03/2018
Supplement Dates Manufacturer Received03/15/2018
03/15/2018
Supplement Dates FDA Received04/04/2018
04/25/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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