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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CL ELECTRODE; ELECTRODE, ION-SPECIFIC, CHLORIDE

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ROCHE DIAGNOSTICS CL ELECTRODE; ELECTRODE, ION-SPECIFIC, CHLORIDE Back to Search Results
Catalog Number ASKU
Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/23/2024
Event Type  malfunction  
Event Description
The initial reporter stated they received discrepant ise results for 8 patient samples tested on a cobas 6000 c (501) module.Results for the following parameters are affected: na electrode, k electrode, and cl electrode.This medwatch will apply to the cl electrode.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the na electrode and refer to the medwatch with a1.Patient identifier (b)(6) for information related to the k electrode.Refer to the attachment for all patient data.All results in the "repeat 1" column, except for sample 2, were automatically repeats performed on the complained analyzer.Results in the "repeat 2" column were measured on a second analyzer.Discrepancies were first found for samples 1 and 2.No questionable results from these samples were reported outside of the laboratory.The samples were repeated and the repeat values were deemed correct.The customer performed maintenance on the analyzer, but this did not resolve the issue.The customer then reported they had result discrepancies for samples 3-8.
 
Manufacturer Narrative
The serial number of the c501 analyzer is (b)(6).The customer noted that the issue is still occurring.The investigation is ongoing.
 
Manufacturer Narrative
For all samples, no questionable results were reported outside of the laboratory and the repeat values were deemed correct.One level of control was outside of range for sodium.One level of control was also outside of range for all ise tests.The sample centrifugation time may have been shorter and the speed may have been higher than recommended by the tube manufacturer.The field service engineer found an issue with a probe slider.The slider was replaced.An issue was also found with some valves.The valves were replaced and the ise units were cleaned.The engineer ran activator on the ise system.The customer ran controls and these passed.No further issues occurred after these actions.The investigation determined the service actions resolved the issue.
 
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Brand Name
CL ELECTRODE
Type of Device
ELECTRODE, ION-SPECIFIC, CHLORIDE
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
HITACHI HIGH TECH CORP.
882 ichige hitachinaka
ibaraki 312-8 504
JA   312-8504
Manufacturer Contact
amy nelson
9115 hague road
indianapolis, IN 46250-0457
MDR Report Key18796302
MDR Text Key336436937
Report Number1823260-2024-00569
Device Sequence Number1
Product Code CGZ
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K060373
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/11/2024
2 Devices were Involved in the Event: 1   2  
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 NumberASKU
Device Lot NumberK2614
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/02/2024
Initial Date FDA Received02/28/2024
Supplement Dates Manufacturer Received03/04/2024
Supplement Dates FDA Received03/11/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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