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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 123 <4> SYSTEM; BLOOD GAS ANALYZER

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ROCHE DIAGNOSTICS COBAS B 123 <4> SYSTEM; BLOOD GAS ANALYZER Back to Search Results
Catalog Number 05122287001
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/22/2014
Event Type  malfunction  
Manufacturer Narrative
A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.The field service representative performed additional comparisons on both instruments with the same syringe.These measurements showed only moderate differences between the results.It was determined the instrument performed as expected.A pre-analytic issue was possible as the po2 value can increase within a couple of minutes and rolling of the syringe between the hands of the operator can improve the oxygen transfer within the sample and form foam.
 
Event Description
The customer discovered questionable po2 results when the results were compared to cobas b123 analyzer serial number (b)(4).The samples were collected from patients after a breath therapy.Data was provided for three patient samples.Refer to the attachment to the medwatch for all data.Information concerning which results were reported outside the lab was requested, but it was unknown.There was no death, injury, or admission to a medical facility.The lot number for the cobas b123 sensor cartridge was 21543281.The expiration date was requested, but was not provided.
 
Manufacturer Narrative
This event occurred in (b)(6).(b)(4).
 
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Brand Name
COBAS B 123 <4> SYSTEM
Type of Device
BLOOD GAS ANALYZER
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250
Manufacturer (Section G)
ROCHE INSTRUMENT CENTER AG TEGIMENTA
forrenstrasse
na
rotkreuz 6343
SZ   6343
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key4255168
MDR Text Key12978293
Report Number1823260-2014-08952
Device Sequence Number1
Product Code CHL
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K111188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 03/16/2015
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 Nurse
Device Catalogue Number05122287001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Event Location Laboratory
Initial Date Manufacturer Received 10/23/2014
Initial Date FDA Received11/17/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/16/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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