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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS 9180 ELECTROLYTE ANALYZER
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ROCHE DIAGNOSTICS 9180 ELECTROLYTE ANALYZER Back to Search Results
Model Number ISE 9180
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2023
Event Type  malfunction  
Event Description
There was an allegation of questionable gen.2 ise indirect for na results for 4 patient samples on a 9180 avl electrolyte analyzer compared to a radiometer abl90 flex.For sample 1, the 9180 na serum result was 138 mmol/l.The abl90 na serum result 15 minutes later was 145 mmol/l.For sample 2, the 9180 na serum result was 131 mmol/l.The abl90 na serum result 15 minutes later was 137 mmol/l.For sample 3, the first 9180 na serum result was 135 mmol/l.The second 9180 na serum result 20 minutes later was 128 mmol/l.The abl90 na serum result was 134 mmol/l.For sample 4, the first 9180 na serum result was 121 mmol/l.The second 9180 na serum result 20 minutes later was 113 mmol/l.The abl90 na serum result was 121 mmol/l.The initial results were reported outside of the laboratory.The results from the abl90 analyzer were deemed correct.The sodium electrode lot number is 21523347.The expiration date was requested but not provided.
 
Manufacturer Narrative
The investigation is ongoing.
 
Manufacturer Narrative
The field service engineer (fse) performed performance testing on the electrodes.The investigation did not identify a product problem.The root cause of the event could not be determined.
 
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Brand Name
9180 ELECTROLYTE ANALYZER
Type of Device
ELECTROLYTE ANALYZER
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
ROCHE INSTRUMENT CENTER AG TEGIMENTA
forrenstrasse
na
rotkreuz 6343
SZ   6343
Manufacturer Contact
amy nelson
9115 hague road
na
indianapolis, IN 46250
3174767531
MDR Report Key16700283
MDR Text Key313208388
Report Number1823260-2023-01123
Device Sequence Number1
Product Code JFP
UDI-Device Identifier04015630031832
UDI-Public04015630031832
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K961458
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberISE 9180
Device Catalogue Number03157334001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/01/2023
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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